Breast Cancer
Conditions
Keywords
Prospective, Multicenter, Observational study, Japan, hormone receptor - positive/human epidermal growth factor 2 - negative (HR+/HER2-) advanced breast cancer, Palbociclib, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (items) (EORTC-QLQ-C30), Physical activity
Brief summary
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Interventions
DEVICEWearable device
As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Sponsors
Japan Breast Cancer Research Group
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult women (≥ 20 years of age) 2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent. 3. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy. 4. Initiating first or second line treatment at study entry with one of the following therapies: palbociclib plus endocrine therapy or endocrine monotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status = 0\ 1. 6. Owns or has regular access to an Apple iPhone or Android phone. 7. Willing and able to complete collection of data via smartphone-based application. 8. Willing and able to wear the wearable device for approximately 6 months. 9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 10. Able to read and understand Japanese
Exclusion criteria
1. The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study. 2. The patient is on active treatment for other malignancies other than ABC. 3. The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sedentary Time Wearing at Week 24 | Baseline, Week 24 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 5 | Baseline, Week 5 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 6 | Baseline, Week 6 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 7 | Baseline, Week 7 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 8 | Baseline, Week 8 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 9 | Baseline, Week 9 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 10 | Baseline, Week 10 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 11 | Baseline, Week 11 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 12 | Baseline, Week 12 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 13 | Baseline, Week 13 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 14 | Baseline, Week 14 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 15 | Baseline, Week 15 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 16 | Baseline, Week 16 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 17 | Baseline, Week 17 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 18 | Baseline, Week 18 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 19 | Baseline, Week 19 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 20 | Baseline, Week 20 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 21 | Baseline, Week 21 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 22 | Baseline, Week 22 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 23 | Baseline, Week 23 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1 | Baseline, Cycle 1 (1 cycle = 4 Weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2 | Baseline, Cycle 2 (1 cycle = 4 weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3 | Baseline, Cycle 3 (1 cycle = 4 Weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4 | Baseline, Cycle 4 (1 cycle = 4 Weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in Sedentary Time Wearing at Week 4 | Baseline, Week 4 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5 | Baseline, Cycle 5 (1 cycle = 4 Weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6 | Baseline, Cycle 6 (1 cycle = 4 Weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start. |
| Change From Baseline in Sedentary Time Wearing at Week 1 | Baseline, Week 1 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 2 | Baseline, Week 2 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
| Change From Baseline in Sedentary Time Wearing at Week 3 | Baseline, Week 3 | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant. |
| Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Total estimated steps taken per week were reported in this outcome measure. |
| Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks) | AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement. |
| Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe. |
| Number of Participants According to Fatigue Interference Based on PRO-CTCAE | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much. |
| Number of Participants According to Pain Severity Based on PRO-CTCAE | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe. |
| Number of Participants According to Pain Interference Based on PRO-CTCAE | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much. |
| Number of Participants According to Pain Frequency Based on PRO-CTCAE | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly. |
| Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled | Before and after disease progression during the observation period (maximum up to 24 weeks) | Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (\>) 25% increase in sum of longest diameter of target lesions compared to baseline. |
| Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled | Before and after disease progression during the observation period (maximum up to 24 weeks) | Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline. |
| MVPA Before and After Disease Progression: Group 1 and 2 Pooled | Before and after disease progression during the observation period (maximum up to 24 weeks) | Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline. |
| EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Before and after disease progression during the observation period (maximum up to 24 weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical \[P\],role \[R\],emotional \[E\],cognitive \[C\], and social \[S\] functioning \[F\], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline. |
| Number of Participants With Treatment Satisfaction | Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks) | Treatment satisfaction was evaluated with single item question (eg,How satisfied are you with your current breast cancer treatment?) using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied). |
| Number of Participants According to Starting Dose of Palbociclib Treatment | Baseline | Number of participants according to starting dose of palbociclib treatment (125 milligrams \[mg\], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start. |
| Number of Participants Who Had Any Palbociclib Dose Reduction | Up to 24 Weeks | — |
| Number of Participants Who Had Any Palbociclib Dose Interruption | Up to 24 Weeks | — |
| Number of Participants With Cycle Delay in Palbociclib Treatment | Up to 24 Weeks | — |
| Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks) | The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical \[P\], role \[R\], emotional \[E\], cognitive \[C\], and social \[S\] functioning \[F\]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning. |
Countries
Japan
Participant flow
Recruitment details
This prospective, multicenter, observational study evaluated patient reported outcome (PRO) and physical activity using smartphone-based application and wearable device in Japanese participants diagnosed with hormone receptor positive (HR+) /human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC), who received palbociclib plus endocrine therapy or endocrine monotherapy.
Pre-assignment details
A total of 99 participants were enrolled into the study and were observed for maximum up to 24 Weeks.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks. | 78 |
| Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks. | 21 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Progressive disease | 3 | 1 |
Baseline characteristics
| Characteristic | Group 2: Endocrine Monotherapy | Total | Group 1: Palbociclib Plus Endocrine Therapy |
|---|---|---|---|
| Age, Continuous | 56.3 Years STANDARD_DEVIATION 10.1 | 57.0 Years STANDARD_DEVIATION 10 | 57.2 Years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants | 99 Participants | 78 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 99 Participants | 78 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 78 | 0 / 21 |
| other Total, other adverse events | 65 / 78 | 5 / 21 |
| serious Total, serious adverse events | 3 / 78 | 0 / 21 |
Outcome results
Primary
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 2 (1 cycle = 4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2 | 6.08 Units on a scale | Standard Deviation 21.38 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2 | 0.42 Units on a scale | Standard Deviation 23.95 |
Primary
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 3 (1 cycle = 4 Weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3 | 8.00 Units on a scale | Standard Deviation 21.61 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3 | 5.70 Units on a scale | Standard Deviation 27.22 |
Primary
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 4 (1 cycle = 4 Weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4 | 6.62 Units on a scale | Standard Deviation 20.5 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4 | -0.93 Units on a scale | Standard Deviation 30.5 |
Primary
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 5 (1 cycle = 4 Weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5 | 4.23 Units on a scale | Standard Deviation 20.79 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5 | -2.78 Units on a scale | Standard Deviation 28.11 |
Primary
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 6 (1 cycle = 4 Weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6 | 4.78 Units on a scale | Standard Deviation 22.78 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6 | 2.94 Units on a scale | Standard Deviation 29.01 |
Primary
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 1 (1 cycle = 4 Weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1 | 0.77 Units on a scale | Standard Deviation 19.25 |
| Group 2: Endocrine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1 | -0.42 Units on a scale | Standard Deviation 20.67 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 1
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 1
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 1 | 18 Minutes | Standard Deviation 83 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 1 | 13 Minutes | Standard Deviation 100 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 10
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 10
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 10 | -8 Minutes | Standard Deviation 130 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 10 | -4 Minutes | Standard Deviation 146 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 11
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 11
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 11 | -16 Minutes | Standard Deviation 132 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 11 | -57 Minutes | Standard Deviation 207 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 12
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 12
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 12 | -5 Minutes | Standard Deviation 137 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 12 | -66 Minutes | Standard Deviation 190 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 13
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 13
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 13 | -10 Minutes | Standard Deviation 145 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 13 | -14 Minutes | Standard Deviation 112 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 14
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 14
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 14 | -7 Minutes | Standard Deviation 138 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 14 | -14 Minutes | Standard Deviation 136 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 15
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 15
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 15 | -10 Minutes | Standard Deviation 134 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 15 | -60 Minutes | Standard Deviation 133 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 16
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 16
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 16 | -3 Minutes | Standard Deviation 128 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 16 | -45 Minutes | Standard Deviation 179 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 17
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 17
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 17 | -6 Minutes | Standard Deviation 128 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 17 | -18 Minutes | Standard Deviation 106 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 18
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 18
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 18 | 2 Minutes | Standard Deviation 140 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 18 | -24 Minutes | Standard Deviation 134 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 19
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 19
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 19 | -2 Minutes | Standard Deviation 136 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 19 | -39 Minutes | Standard Deviation 82 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 2
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 2
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 2 | 8 Minutes | Standard Deviation 114 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 2 | -32 Minutes | Standard Deviation 130 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 20
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 20
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 20 | -6 Minutes | Standard Deviation 147 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 20 | -64 Minutes | Standard Deviation 179 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 21
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 21
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 21 | 11 Minutes | Standard Deviation 145 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 21 | -32 Minutes | Standard Deviation 178 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 22
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 22
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 22 | 2 Minutes | Standard Deviation 138 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 22 | -46 Minutes | Standard Deviation 143 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 23
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 23
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 23 | -1 Minutes | Standard Deviation 140 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 23 | -70 Minutes | Standard Deviation 128 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 24
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 24
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 24 | -22 Minutes | Standard Deviation 161 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 24 | -102 Minutes | Standard Deviation 176 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 3
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 3
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 3 | 12 Minutes | Standard Deviation 105 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 3 | -8 Minutes | Standard Deviation 159 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 4
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 4
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 4 | -5 Minutes | Standard Deviation 98 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 4 | -43 Minutes | Standard Deviation 173 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 5
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 5
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 5 | -7 Minutes | Standard Deviation 121 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 5 | -50 Minutes | Standard Deviation 149 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 6
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 6
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 6 | -13 Minutes | Standard Deviation 118 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 6 | -27 Minutes | Standard Deviation 146 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 7
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 7
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 7 | -9 Minutes | Standard Deviation 114 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 7 | -67 Minutes | Standard Deviation 186 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 8
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 8
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 8 | -5 Minutes | Standard Deviation 114 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 8 | -29 Minutes | Standard Deviation 125 |
Primary
Change From Baseline in Sedentary Time Wearing at Week 9
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 9
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Sedentary Time Wearing at Week 9 | -8 Minutes | Standard Deviation 130 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Sedentary Time Wearing at Week 9 | -20 Minutes | Standard Deviation 201 |
Secondary
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 2 | -1 Minutes | Standard Deviation 38 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 13 | 2 Minutes | Standard Deviation 51 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 7 | -3 Minutes | Standard Deviation 58 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 14 | 1 Minutes | Standard Deviation 58 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 4 | -2 Minutes | Standard Deviation 41 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 15 | 0 Minutes | Standard Deviation 68 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 8 | -2 Minutes | Standard Deviation 49 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 16 | -2 Minutes | Standard Deviation 55 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 1 | -1 Minutes | Standard Deviation 28 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 17 | -6 Minutes | Standard Deviation 47 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 9 | 5 Minutes | Standard Deviation 55 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 18 | -5 Minutes | Standard Deviation 59 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 5 | 5 Minutes | Standard Deviation 48 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 19 | -5 Minutes | Standard Deviation 64 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 10 | -1 Minutes | Standard Deviation 57 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 20 | -6 Minutes | Standard Deviation 44 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 3 | -4 Minutes | Standard Deviation 32 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 21 | -1 Minutes | Standard Deviation 51 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 22 | -2 Minutes | Standard Deviation 40 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 11 | -2 Minutes | Standard Deviation 47 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 23 | 3 Minutes | Standard Deviation 53 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 6 | 4 Minutes | Standard Deviation 35 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 24 | 3 Minutes | Standard Deviation 49 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 12 | 1 Minutes | Standard Deviation 50 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 15 | -2 Minutes | Standard Deviation 20 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 1 | -7 Minutes | Standard Deviation 20 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 2 | -9 Minutes | Standard Deviation 20 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 3 | -10 Minutes | Standard Deviation 22 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 4 | -2 Minutes | Standard Deviation 27 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 5 | -4 Minutes | Standard Deviation 23 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 6 | -5 Minutes | Standard Deviation 27 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 7 | -12 Minutes | Standard Deviation 24 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 8 | 1 Minutes | Standard Deviation 16 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 9 | -6 Minutes | Standard Deviation 26 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 10 | 0 Minutes | Standard Deviation 23 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 11 | -4 Minutes | Standard Deviation 28 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 12 | -6 Minutes | Standard Deviation 19 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 13 | 10 Minutes | Standard Deviation 21 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 14 | 1 Minutes | Standard Deviation 22 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 21 | -11 Minutes | Standard Deviation 25 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 16 | -8 Minutes | Standard Deviation 29 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 17 | 0 Minutes | Standard Deviation 24 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 18 | 1 Minutes | Standard Deviation 26 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 19 | -9 Minutes | Standard Deviation 36 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 20 | 0 Minutes | Standard Deviation 30 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 22 | -5 Minutes | Standard Deviation 32 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 23 | 3 Minutes | Standard Deviation 33 |
| Group 2: Endocrine Monotherapy | Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 24 | -4 Minutes | Standard Deviation 23 |
Secondary
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical \[P\], role \[R\], emotional \[E\], cognitive \[C\], and social \[S\] functioning \[F\]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants analyzed for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 4 | 9.25 Units on a scale | Standard Deviation 19.12 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 3 | 4.28 Units on a scale | Standard Deviation 21.02 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 5 | 8.8 Units on a scale | Standard Deviation 18.57 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 2 | 3.15 Units on a scale | Standard Deviation 14.14 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 6 | 9.31 Units on a scale | Standard Deviation 16.64 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 4 | 2.97 Units on a scale | Standard Deviation 22.8 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 1 | 1.75 Units on a scale | Standard Deviation 16.46 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 6 | 0.39 Units on a scale | Standard Deviation 18.71 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 2 | 1.13 Units on a scale | Standard Deviation 16.16 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 5 | 2.35 Units on a scale | Standard Deviation 24.12 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 3 | 0.23 Units on a scale | Standard Deviation 16.44 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 4 | 3.11 Units on a scale | Standard Deviation 17.43 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 4 | -091 Units on a scale | Standard Deviation 20.39 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 6 | 0.98 Units on a scale | Standard Deviation 25.58 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 5 | -2.58 Units on a scale | Standard Deviation 19.03 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 1 | -1.75 Units on a scale | Standard Deviation 23.03 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 6 | -3.19 Units on a scale | Standard Deviation 21.01 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 1 | 8.22 Units on a scale | Standard Deviation 16.69 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 1 | 1.32 Units on a scale | Standard Deviation 21.39 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 3 | 1.53 Units on a scale | Standard Deviation 16.65 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 2 | 2.7 Units on a scale | Standard Deviation 22.25 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 2 | 10.59 Units on a scale | Standard Deviation 18.21 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 3 | 1.35 Units on a scale | Standard Deviation 22.03 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 2 | 2.03 Units on a scale | Standard Deviation 20.26 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 4 | -0.68 Units on a scale | Standard Deviation 23.31 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 3 | 10.36 Units on a scale | Standard Deviation 16.31 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 5 | -1.17 Units on a scale | Standard Deviation 24.29 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle5 | 2.72 Units on a scale | Standard Deviation 19.7 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 6 | -2.45 Units on a scale | Standard Deviation 21.98 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 1 | -1.58 Units on a scale | Standard Deviation 14.6 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 6 | 1.96 Units on a scale | Standard Deviation 18.52 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 1 | -2.33 Units on a scale | Standard Deviation 15.93 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 2 | 1.33 Units on a scale | Standard Deviation 11.77 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 3 | 1.75 Units on a scale | Standard Deviation 14.2 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 4 | -1.11 Units on a scale | Standard Deviation 10.29 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle5 | -8.44 Units on a scale | Standard Deviation 17.9 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | PF: Change at Cycle 6 | -1.18 Units on a scale | Standard Deviation 13.99 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 1 | -4.17 Units on a scale | Standard Deviation 16.11 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 2 | -1.67 Units on a scale | Standard Deviation 20.16 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 3 | -4.39 Units on a scale | Standard Deviation 19.12 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF: Change at Cycle 4 | -4.63 Units on a scale | Standard Deviation 29.6 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 5 | -10 Units on a scale | Standard Deviation 23.4 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | RF Change at Cycle 6 | -2.94 Units on a scale | Standard Deviation 24.46 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 1 | 0.83 Units on a scale | Standard Deviation 16.42 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 2 | -2.5 Units on a scale | Standard Deviation 10.85 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 3 | -1.75 Units on a scale | Standard Deviation 12.9 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 4 | -5.09 Units on a scale | Standard Deviation 19.83 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 5 | -2.22 Units on a scale | Standard Deviation 11.12 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | EF: Change at Cycle 6 | -3.43 Units on a scale | Standard Deviation 15.33 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 1 | -2.5 Units on a scale | Standard Deviation 19.7 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 2 | -3.33 Units on a scale | Standard Deviation 17.61 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 3 | -7.02 Units on a scale | Standard Deviation 23.12 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 4 | -8.33 Units on a scale | Standard Deviation 20.01 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 5 | -2.22 Units on a scale | Standard Deviation 22.6 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | CF: Change at Cycle 6 | -7.84 Units on a scale | Standard Deviation 23.66 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 1 | -0.83 Units on a scale | Standard Deviation 14.78 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 2 | 4.17 Units on a scale | Standard Deviation 20.86 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 3 | 4.39 Units on a scale | Standard Deviation 19.12 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 4 | -2.78 Units on a scale | Standard Deviation 18.3 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | SF: Change at Cycle 5 | -6.67 Units on a scale | Standard Deviation 25.04 |
Secondary
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 1 | 0.15 Units on a scale | Standard Deviation 17.54 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 2 | -2.4 Units on a scale | Standard Deviation 16.27 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 3 | -3.3 Units on a scale | Standard Deviation 18.18 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 4 | -1.52 Units on a scale | Standard Deviation 21.14 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 5 | -0.78 Units on a scale | Standard Deviation 22.72 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 6 | -0.49 Units on a scale | Standard Deviation 23.39 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 1 | 0.66 Units on a scale | Standard Deviation 16.2 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 2 | -2.03 Units on a scale | Standard Deviation 12.93 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 3 | -1.13 Units on a scale | Standard Deviation 15.44 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 4 | -3.2 Units on a scale | Standard Deviation 14.61 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 5 | -2.58 Units on a scale | Standard Deviation 15.85 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 6 | -3.43 Units on a scale | Standard Deviation 13.37 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 1 | -0.88 Units on a scale | Standard Deviation 16.75 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 2 | -4.73 Units on a scale | Standard Deviation 19.99 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 3 | -5.86 Units on a scale | Standard Deviation 22.65 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 4 | -5.02 Units on a scale | Standard Deviation 26.01 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 5 | -5.4 Units on a scale | Standard Deviation 25.94 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 6 | 0 Units on a scale | Standard Deviation 24.43 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 2 | 1.67 Units on a scale | Standard Deviation 23.51 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 1 | -1.11 Units on a scale | Standard Deviation 16.48 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 4 | -7.41 Units on a scale | Standard Deviation 24.4 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 2 | -0.56 Units on a scale | Standard Deviation 20.86 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 6 | 2.94 Units on a scale | Standard Deviation 23 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 3 | -4.68 Units on a scale | Standard Deviation 19 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 5 | -6.67 Units on a scale | Standard Deviation 28.73 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 4 | 3.7 Units on a scale | Standard Deviation 21.56 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 3 | -3.51 Units on a scale | Standard Deviation 24.58 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 5 | 3.7 Units on a scale | Standard Deviation 25.77 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 6 | -5.88 Units on a scale | Standard Deviation 26.31 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Fatigue: Change at Cycle 6 | -1.31 Units on a scale | Standard Deviation 18.79 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 5 | 12.22 Units on a scale | Standard Deviation 24.77 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 1 | -4.17 Units on a scale | Standard Deviation 25.86 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 1 | 4.17 Units on a scale | Standard Deviation 16.99 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 2 | -5.83 Units on a scale | Standard Deviation 23.12 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Pain: Change at Cycle 4 | 2.78 Units on a scale | Standard Deviation 28.73 |
| Group 2: Endocrine Monotherapy | Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 | Nausea, Vomiting: Change at Cycle 3 | -6.14 Units on a scale | Standard Deviation 23.71 |
Secondary
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Total estimated steps taken per week were reported in this outcome measure.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 7 | 82 Steps per week | Standard Deviation 1199 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 2 | 0 Steps per week | Standard Deviation 996 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 3 | -17 Steps per week | Standard Deviation 1104 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 4 | -17 Steps per week | Standard Deviation 1004 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 5 | 171 Steps per week | Standard Deviation 1031 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 6 | 353 Steps per week | Standard Deviation 1253 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 1 | -164 Steps per week | Standard Deviation 927 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 8 | 147 Steps per week | Standard Deviation 1376 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 9 | 263 Steps per week | Standard Deviation 1242 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 10 | 279 Steps per week | Standard Deviation 1470 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 11 | 82 Steps per week | Standard Deviation 1324 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 12 | 260 Steps per week | Standard Deviation 1514 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 13 | 285 Steps per week | Standard Deviation 1355 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 14 | 395 Steps per week | Standard Deviation 1526 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 15 | 79 Steps per week | Standard Deviation 1490 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 16 | 188 Steps per week | Standard Deviation 1540 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 17 | 81 Steps per week | Standard Deviation 1477 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 18 | 207 Steps per week | Standard Deviation 1418 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 19 | 174 Steps per week | Standard Deviation 1495 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 20 | 254 Steps per week | Standard Deviation 1234 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 21 | 518 Steps per week | Standard Deviation 1478 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 22 | 334 Steps per week | Standard Deviation 1174 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 23 | 321 Steps per week | Standard Deviation 1579 |
| Group 1: Palbociclib Plus Endocrine Therapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 24 | 447 Steps per week | Standard Deviation 1860 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 23 | 691 Steps per week | Standard Deviation 1865 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 1 | -340 Steps per week | Standard Deviation 1219 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 13 | 940 Steps per week | Standard Deviation 1808 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 2 | -39 Steps per week | Standard Deviation 1413 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 19 | 155 Steps per week | Standard Deviation 2092 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 3 | -397 Steps per week | Standard Deviation 1349 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 14 | 389 Steps per week | Standard Deviation 1787 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 4 | 13 Steps per week | Standard Deviation 1608 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 22 | 362 Steps per week | Standard Deviation 1875 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 5 | 165 Steps per week | Standard Deviation 1618 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 15 | 267 Steps per week | Standard Deviation 1787 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 6 | 54 Steps per week | Standard Deviation 1468 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 20 | 726 Steps per week | Standard Deviation 1820 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 7 | -425 Steps per week | Standard Deviation 1388 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 16 | 387 Steps per week | Standard Deviation 2142 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 8 | 481 Steps per week | Standard Deviation 1733 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 24 | 202 Steps per week | Standard Deviation 1690 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 9 | -102 Steps per week | Standard Deviation 1962 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 17 | 718 Steps per week | Standard Deviation 1743 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 10 | 251 Steps per week | Standard Deviation 1869 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 21 | 166 Steps per week | Standard Deviation 2082 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 11 | 177 Steps per week | Standard Deviation 1882 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 18 | 264 Steps per week | Standard Deviation 2274 |
| Group 2: Endocrine Monotherapy | Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Change at Week 12 | 168 Steps per week | Standard Deviation 1806 |
Secondary
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical \[P\],role \[R\],emotional \[E\],cognitive \[C\], and social \[S\] functioning \[F\], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | GHS (Before disease progression) | 69.4 Units on a scale | Standard Deviation 17.5 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | GHS (After disease progression) | 53.3 Units on a scale | Standard Deviation 30 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Physical Functioning (Before disease progression) | 80.6 Units on a scale | Standard Deviation 15.2 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Physical Functioning (After disease progression) | 68.0 Units on a scale | Standard Deviation 30.1 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Role Functioning (Before disease progression) | 86.1 Units on a scale | Standard Deviation 17.2 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Role Functioning (After disease progression) | 65.0 Units on a scale | Standard Deviation 38 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Social Functioning (Before disease progression) | 88.9 Units on a scale | Standard Deviation 16.4 |
| Group 1: Palbociclib Plus Endocrine Therapy | EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled | Social Functioning (After disease progression) | 76.7 Units on a scale | Standard Deviation 27.4 |
Secondary
MVPA Before and After Disease Progression: Group 1 and 2 Pooled
Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | MVPA Before and After Disease Progression: Group 1 and 2 Pooled | Before disease progression | 73 Minutes | Standard Deviation 25 |
| Group 1: Palbociclib Plus Endocrine Therapy | MVPA Before and After Disease Progression: Group 1 and 2 Pooled | After disease progression | 75 Minutes | Standard Deviation 30 |
Secondary
Number of Participants According to Fatigue Interference Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Quite a bit | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Somewhat | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Very Much | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Quite a bit | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Very Much | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Very Much | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Not at all/None/Never | 33 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Not at all/None/Never | 19 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Not at all/None/Never | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | A Little bit | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Not at all/None/Never | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Somewhat | 17 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | A Little bit | 42 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Quite a bit | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Somewhat | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Very Much | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Somewhat | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Not at all/None/Never | 17 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | A Little bit | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | A Little bit | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Quite a bit | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Somewhat | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Quite a bit | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Quite a bit | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Very Much | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Not at all/None/Never | 18 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Somewhat | 23 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | A Little bit | 29 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Not at all/None/Never | 19 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Somewhat | 12 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | A Little bit | 30 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Quite a bit | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | A Little bit | 36 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Very Much | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Very Much | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Very Much | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Somewhat | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Not at all/None/Never | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | A Little bit | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Quite a bit | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Baseline | Very Much | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Not at all/None/Never | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Somewhat | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Quite a bit | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 1 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Not at all/None/Never | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | A Little bit | 9 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Somewhat | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Quite a bit | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 2 | Very Much | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Not at all/None/Never | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Somewhat | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Quite a bit | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 3 | Very Much | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Not at all/None/Never | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Somewhat | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Quite a bit | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 4 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Not at all/None/Never | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | A Little bit | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Somewhat | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 5 | Quite a bit | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Not at all/None/Never | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Somewhat | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Interference Based on PRO-CTCAE | FI: Cycle 6 | Quite a bit | 2 Participants |
Secondary
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Severe | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | None | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Very Severe | 0 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | None | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | None | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Severe | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Mild | 41 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Mild | 41 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Moderate | 19 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Mild | 35 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Severe | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Moderate | 20 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Very Severe | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Moderate | 11 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | None | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Severe | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Mild | 38 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Moderate | 27 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Moderate | 20 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Severe | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Very Severe | 0 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Very Severe | 0 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | None | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | None | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Severe | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Mild | 34 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Mild | 40 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Moderate | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Mild | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Severe | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Moderate | 17 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | None | 27 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Very Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | None | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Mild | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Moderate | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Severe | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Baseline | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | None | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Mild | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Moderate | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Severe | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 1 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | None | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Mild | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Moderate | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 2 | Very Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | None | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Mild | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Moderate | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 3 | Very Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Mild | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Moderate | 9 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 4 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Mild | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Moderate | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Severe | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 5 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Mild | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Moderate | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | FS: Cycle 6 | Severe | 1 Participants |
Secondary
Number of Participants According to Pain Frequency Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Occasionally | 25 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Rarely | 20 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Almost Constantly | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Frequently | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Rarely | 19 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Occasionally | 18 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | None | 18 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Rarely | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Occasionally | 34 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Frequently | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Almost Constantly | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | None | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Rarely | 12 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Occasionally | 39 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Frequently | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Almost Constantly | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | None | 11 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Rarely | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Occasionally | 41 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Frequently | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Almost Constantly | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | None | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Occasionally | 28 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Frequently | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | None | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Rarely | 17 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Almost Constantly | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | None | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Rarely | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Occasionally | 23 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Frequently | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Almost Constantly | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | None | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Frequently | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Almost Constantly | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Rarely | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Rarely | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Frequently | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Frequently | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Almost Constantly | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Occasionally | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Occasionally | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Frequently | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | None | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Occasionally | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Rarely | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Frequently | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Occasionally | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Almost Constantly | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | Almost Constantly | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | None | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | Almost Constantly | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Rarely | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Almost Constantly | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Occasionally | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | None | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Frequently | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Rarely | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Baseline | Almost Constantly | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | None | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | None | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 3 | Occasionally | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Rarely | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Frequently | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Occasionally | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 5 | Rarely | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 4 | None | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 1 | Almost Constantly | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 6 | Frequently | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Frequency Based on PRO-CTCAE | PF: Cycle 2 | None | 3 Participants |
Secondary
Number of Participants According to Pain Interference Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Quite a bit | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Somewhat | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Quite a bit | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | A Little bit | 28 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Somewhat | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | A Little bit | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Quite a bit | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Somewhat | 17 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Very Much | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | A Little bit | 25 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Quite a bit | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Somewhat | 7 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Not at all/None/Never | 39 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | A Little bit | 24 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Very Much | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Not at all/None/Never | 20 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Somewhat | 18 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Quite a bit | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Very Much | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Not at all/None/Never | 24 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | A Little bit | 36 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Quite a bit | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Very Much | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Not at all/None/Never | 26 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Somewhat | 11 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Very Much | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Not at all/None/Never | 29 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | A Little bit | 23 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Not at all/None/Never | 26 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Somewhat | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Very Much | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Not at all/None/Never | 23 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | A Little bit | 27 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Quite a bit | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Very Much | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Quite a bit | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | A Little bit | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Not at all/None/Never | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Somewhat | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Not at all/None/Never | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Not at all/None/Never | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Somewhat | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | A Little bit | 9 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Quite a bit | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Somewhat | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Quite a bit | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | A Little bit | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 2 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Somewhat | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Quite a bit | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Quite a bit | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Not at all/None/Never | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | A Little bit | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | A Little bit | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Somewhat | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Somewhat | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 5 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Quite a bit | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 3 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Very Much | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Very Much | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | A Little bit | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 4 | Not at all/None/Never | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Somewhat | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 6 | Not at all/None/Never | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Quite a bit | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Baseline | Not at all/None/Never | 12 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Interference Based on PRO-CTCAE | PI: Cycle 1 | Very Much | 0 Participants |
Secondary
Number of Participants According to Pain Severity Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Severe | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Moderate | 16 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | None | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Severe | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | None | 12 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Moderate | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Moderate | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | None | 16 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Mild | 35 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Moderate | 18 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Mild | 35 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Moderate | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Severe | 8 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | None | 22 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Mild | 33 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Severe | 4 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Mild | 31 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Moderate | 27 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Mild | 43 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Severe | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Very Severe | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | None | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Mild | 37 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Severe | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Very Severe | 0 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Very Severe | 2 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | None | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Moderate | 15 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Severe | 6 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Very Severe | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | None | 14 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Mild | 30 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Very Severe | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Mild | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Moderate | 8 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | None | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Moderate | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Mild | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | None | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 2 | Very Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Moderate | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Moderate | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | None | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | None | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Mild | 12 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Mild | 6 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Mild | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Severe | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Moderate | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Severe | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Mild | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | None | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 3 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Moderate | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Moderate | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Severe | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Baseline | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 5 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Mild | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 4 | Very Severe | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Severe | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 6 | Severe | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants According to Pain Severity Based on PRO-CTCAE | PS: Cycle 1 | Very Severe | 0 Participants |
Secondary
Number of Participants According to Starting Dose of Palbociclib Treatment
Number of participants according to starting dose of palbociclib treatment (125 milligrams \[mg\], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start.
Time frame: Baseline
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Starting Dose of Palbociclib Treatment | 125 mg | 73 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Starting Dose of Palbociclib Treatment | 100 mg | 5 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants According to Starting Dose of Palbociclib Treatment | 75 mg | 0 Participants |
Secondary
Number of Participants Who Had Any Palbociclib Dose Interruption
Time frame: Up to 24 Weeks
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants Who Had Any Palbociclib Dose Interruption | 31 Participants |
Secondary
Number of Participants Who Had Any Palbociclib Dose Reduction
Time frame: Up to 24 Weeks
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants Who Had Any Palbociclib Dose Reduction | 44 Participants |
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events
AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement.
Time frame: From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Adverse Events | 68 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Serious Adverse Events | 3 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Grade 3 or Higher AEs | 54 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Treatment Related Adverse Events | 66 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Treatment Related Adverse Events | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Adverse Events | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Grade 3 or Higher AEs | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events | Serious Adverse Events | 0 Participants |
Secondary
Number of Participants With Cycle Delay in Palbociclib Treatment
Time frame: Up to 24 Weeks
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Cycle Delay in Palbociclib Treatment | 58 Participants |
Secondary
Number of Participants With Treatment Satisfaction
Treatment satisfaction was evaluated with single item question (eg,How satisfied are you with your current breast cancer treatment?) using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied).
Time frame: Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Very Satisfied | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Dissatisfied | 0 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Neutral | 35 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Neutral | 31 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Neutral | 40 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Satisfied | 33 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Very Satisfied | 10 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Very Satisfied | 11 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Dissatisfied | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Dissatisfied | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Dissatisfied | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Neutral | 30 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Satisfied | 31 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Satisfied | 27 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Very Satisfied | 13 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Neutral | 33 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Dissatisfied | 1 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Satisfied | 29 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Neutral | 29 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Satisfied | 32 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Satisfied | 34 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Very Satisfied | 11 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Very Satisfied | 9 Participants |
| Group 1: Palbociclib Plus Endocrine Therapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Dissatisfied | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Very Satisfied | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Dissatisfied | 1 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Very Satisfied | 4 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Dissatisfied | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Neutral | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Satisfied | 9 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Neutral | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Neutral | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 1 | Satisfied | 5 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Satisfied | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 2 | Very Satisfied | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Dissatisfied | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Neutral | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 3 | Very Satisfied | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Dissatisfied | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Neutral | 10 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Satisfied | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 4 | Very Satisfied | 3 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Dissatisfied | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Satisfied | 11 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 5 | Very Satisfied | 2 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Dissatisfied | 0 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Neutral | 7 Participants |
| Group 2: Endocrine Monotherapy | Number of Participants With Treatment Satisfaction | Cycle 6 | Satisfied | 11 Participants |
Secondary
Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (\>) 25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled | Before disease progression | 574 Minutes | Standard Deviation 246 |
| Group 1: Palbociclib Plus Endocrine Therapy | Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled | After disease progression | 594 Minutes | Standard Deviation 266 |
Secondary
Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled
Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Palbociclib Plus Endocrine Therapy | Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled | Before disease progression | 3601 Steps per week | Standard Deviation 1993 |
| Group 1: Palbociclib Plus Endocrine Therapy | Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled | After disease progression | 3599 Steps per week | Standard Deviation 2017 |