Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
Brief summary
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
Interventions
OTHERnon-interventional
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years or older. 2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent. 3. Documented HR+ (ER+ and/or PR+) tumor based on local standards. 4. Documented HER2- tumor based on local standards. 5. Physician has determined that treatment with palbociclib is indicated. 6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 7. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.
Exclusion criteria
1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment. 2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study). 3. Patients on active treatment for malignancies other than ABC at the time of enrollment. 4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to Real-World Tumor Response | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) | Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered. |
| Real-World Tumor Response Rate | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) | Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants. |
| Real World Progression Free Survival | From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years) | Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment. |
| Overall Survival | From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years) | Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive. |
| Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only | Baseline (last observed measurement prior to treatment start date) | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only | Month 1 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only | Month 2 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only | Month 3 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only | Month 6 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only | Month 9 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only | Month 12 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only | Month 15 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only | Month 18 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only | Month 21 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only | Month 24 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only | Month 27 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only | Month 30 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only | Month 33 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only | Month 36 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only | Month 39 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only | Month 42 | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). |
| Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only | Baseline (last observed measurement prior to treatment start date) | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only | Month 1 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only | Month 2 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only | Month 3 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only | Month 6 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only | Month 9 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only | Month 12 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only | Month 15 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only | Month 18 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only | Month 21 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only | Month 24 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only | Month 27 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only | Month 30 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only | Month 33 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only | Month 36 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only | Month 39 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only | Month 42 | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. |
| Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Baseline (last observed measurement prior to treatment start date) and Month 6 | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. |
| Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Baseline (last observed measurement prior to treatment start date) and Month 12 | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. |
| Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Baseline (last observed measurement prior to treatment start date) and Month 18 | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. |
| Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only | Baseline (last observed measurement prior to treatment start date) | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. |
| Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only | Month 1 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only | Month 2 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only | Month 3 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only | Month 6 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only | Month 9 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only | Month 12 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only | Month 15 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only | Month 18 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. |
| Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only | Month 21 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only | Month 24 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only | Month 27 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only | Month 30 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only | Month 33 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only | Month 36 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only | Month 39 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only | Month 42 | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. |
| Number of Participants With Adverse Events | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) | An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. |
| Number of Participants With Serious Adverse Events | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). | A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. |
| Number of Participants With Any Clinical Laboratory Abnormalities | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). | Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) who were prescribed palbociclib in routine clinical practice across the United States and Canada were enrolled in this prospective observational study. Participants were followed up for approximately 3 years post end of treatment or until withdrawal from the study or death.
Pre-assignment details
A total of 1285 participants were enrolled in the study. However, only 1250 participants initiated treatment with palbociclib.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib + Endocrine Therapy Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included. | 1,250 |
| Total | 1,250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Death | 505 |
| Overall Study | Lost to follow up | 39 |
| Overall Study | No longer willing to participate in study | 101 |
| Overall Study | Other | 148 |
| Overall Study | Study terminated by sponsor | 383 |
Baseline characteristics
| Characteristic | Palbociclib + Endocrine Therapy |
|---|---|
| Age, Continuous | 63.0 Years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 139 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 53 Participants |
| Race (NIH/OMB) White | 1022 Participants |
| Sex: Female, Male Female | 1235 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 505 / 1,250 |
| other Total, other adverse events | 1,035 / 1,250 |
| serious Total, serious adverse events | 403 / 1,250 |
Outcome results
Primary
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Baseline (last observed measurement prior to treatment start date)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.74 |
Primary
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Time frame: Baseline (last observed measurement prior to treatment start date)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1.14 |
Primary
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 12
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only | 17.4 Units on a scale | Standard Deviation 1.55 |
Primary
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 15
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only | 17.5 Units on a scale | Standard Deviation 1.52 |
Primary
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Time frame: Month 18
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1.13 |
Primary
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 1
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1.23 |
Primary
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 21
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only | 17.7 Units on a scale | Standard Deviation 0.91 |
Primary
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 24
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 0.93 |
Primary
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 27
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only | 17.5 Units on a scale | Standard Deviation 1.01 |
Primary
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 2
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only | 17.7 Units on a scale | Standard Deviation 1.08 |
Primary
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 30
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only | 17.3 Units on a scale | Standard Deviation 2.05 |
Primary
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 33
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only | 17.5 Units on a scale | Standard Deviation 1.66 |
Primary
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 36
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only | 17.3 Units on a scale | Standard Deviation 1.5 |
Primary
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 39
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only | 17.3 Units on a scale | Standard Deviation 1.5 |
Primary
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 3
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1 |
Primary
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 42
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only | 16.5 Units on a scale | Standard Deviation 2.12 |
Primary
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 9
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1.47 |
Primary
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 6
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only | 17.6 Units on a scale | Standard Deviation 1.19 |
Primary
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 12
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Global health status/QoL | 2.5 Units on a scale | Standard Deviation 23.1 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Dyspnoea | -1.8 Units on a scale | Standard Deviation 29.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Insomnia | -3.1 Units on a scale | Standard Deviation 32.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Financial difficulties | -3.1 Units on a scale | Standard Deviation 28.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Social functioning | 3.4 Units on a scale | Standard Deviation 29 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Fatigue | -0.4 Units on a scale | Standard Deviation 25.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Nausea and vomiting | -1.3 Units on a scale | Standard Deviation 21.2 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Appetite loss | -5.1 Units on a scale | Standard Deviation 32.1 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Constipation | -1.9 Units on a scale | Standard Deviation 26.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Diarrhoea | 0.1 Units on a scale | Standard Deviation 23.5 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Physical functioning | 1.2 Units on a scale | Standard Deviation 20 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Role functioning | 4.5 Units on a scale | Standard Deviation 32.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Emotional functioning | 4.7 Units on a scale | Standard Deviation 20.4 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Cognitive functioning | 0.1 Units on a scale | Standard Deviation 21.5 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Pain | -5.7 Units on a scale | Standard Deviation 30.2 |
Primary
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 18
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Global health status/QoL | 2.5 Units on a scale | Standard Deviation 24.5 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Dyspnoea | 0.4 Units on a scale | Standard Deviation 28.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Insomnia | -3.5 Units on a scale | Standard Deviation 32.8 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Diarrhoea | 0.8 Units on a scale | Standard Deviation 26.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Financial difficulties | -2.5 Units on a scale | Standard Deviation 30.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Physical functioning | 1.6 Units on a scale | Standard Deviation 21.6 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Role functioning | 6.0 Units on a scale | Standard Deviation 33.7 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Emotional functioning | 5.9 Units on a scale | Standard Deviation 19.4 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Social functioning | 4.8 Units on a scale | Standard Deviation 28.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Fatigue | -1.8 Units on a scale | Standard Deviation 26 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Nausea and vomiting | -2.2 Units on a scale | Standard Deviation 22.1 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Pain | -7.6 Units on a scale | Standard Deviation 31.8 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Appetite loss | -4.7 Units on a scale | Standard Deviation 31.7 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Constipation | -1.4 Units on a scale | Standard Deviation 30.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Cognitive functioning | -0.9 Units on a scale | Standard Deviation 22.2 |
Primary
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 6
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Global health status/QoL | 3.5 Units on a scale | Standard Deviation 22.5 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Dyspnoea | -1.9 Units on a scale | Standard Deviation 27.7 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Insomnia | -0.9 Units on a scale | Standard Deviation 32.8 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Appetite loss | -4.5 Units on a scale | Standard Deviation 31.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Emotional functioning | 4.9 Units on a scale | Standard Deviation 20.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Cognitive functioning | 0.6 Units on a scale | Standard Deviation 20.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Social functioning | 3.9 Units on a scale | Standard Deviation 27.2 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Fatigue | -0.7 Units on a scale | Standard Deviation 25 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Nausea and vomiting | -1.7 Units on a scale | Standard Deviation 20.9 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Pain | -6.9 Units on a scale | Standard Deviation 29.8 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Constipation | -1.7 Units on a scale | Standard Deviation 29.1 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Diarrhoea | 0.5 Units on a scale | Standard Deviation 24.8 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Financial difficulties | -0.7 Units on a scale | Standard Deviation 30.4 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Physical functioning | 1.9 Units on a scale | Standard Deviation 19.3 |
| Palbociclib + Endocrine Therapy | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | Role functioning | 4.2 Units on a scale | Standard Deviation 31.5 |
Primary
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 12
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only | 0.8 Units on a scale | Standard Deviation 0.75 |
Primary
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 15
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only | 0.8 Units on a scale | Standard Deviation 0.75 |
Primary
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 18
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.74 |
Primary
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 1
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.73 |
Primary
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 21
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only | 0.8 Units on a scale | Standard Deviation 0.82 |
Primary
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 24
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.81 |
Primary
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 2
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.7 |
Primary
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 30
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only | 0.9 Units on a scale | Standard Deviation 0.86 |
Primary
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 33
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only | 0.9 Units on a scale | Standard Deviation 0.7 |
Primary
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 39
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only | 0.4 Units on a scale | Standard Deviation 0.55 |
Primary
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 3
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only | 0.7 Units on a scale | Standard Deviation 0.71 |
Primary
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 42
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only | 0.5 Units on a scale | Standard Deviation 0.71 |
Primary
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 6
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only | 0.8 Units on a scale | Standard Deviation 0.73 |
Primary
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 9
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only | 0.8 Units on a scale | Standard Deviation 0.71 |
Primary
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 27
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only | 0.9 Units on a scale | Standard Deviation 0.88 |
Primary
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 36
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only | 0.6 Units on a scale | Standard Deviation 0.53 |
Primary
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Baseline (last observed measurement prior to treatment start date)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only | 13.4 Units on a scale | Standard Deviation 2.24 |
Primary
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 12
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only | 13.7 Units on a scale | Standard Deviation 1.97 |
Primary
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 15
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only | 13.6 Units on a scale | Standard Deviation 2.06 |
Primary
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 18
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only | 13.4 Units on a scale | Standard Deviation 2.26 |
Primary
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 1
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only | 13.3 Units on a scale | Standard Deviation 2.23 |
Primary
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 21
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only | 13.4 Units on a scale | Standard Deviation 1.7 |
Primary
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 24
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only | 13.5 Units on a scale | Standard Deviation 2.33 |
Primary
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 27
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only | 13.3 Units on a scale | Standard Deviation 2.17 |
Primary
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 2
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only | 13.4 Units on a scale | Standard Deviation 2.36 |
Primary
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 30
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only | 13.1 Units on a scale | Standard Deviation 1.98 |
Primary
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 33
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only | 13.3 Units on a scale | Standard Deviation 1.89 |
Primary
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 36
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only | 14.1 Units on a scale | Standard Deviation 1.44 |
Primary
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 39
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only | 13.5 Units on a scale | Standard Deviation 2.65 |
Primary
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 3
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only | 13.4 Units on a scale | Standard Deviation 2.2 |
Primary
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 42
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only | 13.0 Units on a scale | Standard Deviation 1.41 |
Primary
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 6
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only | 13.5 Units on a scale | Standard Deviation 2.05 |
Primary
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 9
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only | 13.7 Units on a scale | Standard Deviation 1.9 |
Primary
Number of Participants According to Real-World Tumor Response
Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.
Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Population: Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | Overall | Stable disease | 499 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | Overall | Progressive disease | 223 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | Overall | Indeterminate | 146 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 1 Line of treatment | Complete response | 58 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 1 Line of treatment | Progressive disease | 144 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 1 Line of treatment | Indeterminate | 106 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 2 or more lines of treatment | Complete response | 14 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 2 or more lines of treatment | Partial Response | 62 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 2 or more lines of treatment | Stable disease | 147 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 2 or more lines of treatment | Progressive disease | 79 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 2 or more lines of treatment | Indeterminate | 40 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | Overall | Complete response | 72 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | Overall | Partial Response | 310 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 1 Line of treatment | Partial Response | 248 Participants |
| Palbociclib + Endocrine Therapy | Number of Participants According to Real-World Tumor Response | 1 Line of treatment | Stable disease | 352 Participants |
Primary
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib + Endocrine Therapy | Number of Participants With Adverse Events | 1123 Participants |
Primary
Number of Participants With Any Clinical Laboratory Abnormalities
Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib + Endocrine Therapy | Number of Participants With Any Clinical Laboratory Abnormalities | 1170 Participants |
Primary
Number of Participants With Serious Adverse Events
A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib + Endocrine Therapy | Number of Participants With Serious Adverse Events | 403 Participants |
Primary
Overall Survival
Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.
Time frame: From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Overall Survival | Overall | 42.3 Months |
| Palbociclib + Endocrine Therapy | Overall Survival | 1 line of treatment | 48.5 Months |
| Palbociclib + Endocrine Therapy | Overall Survival | 2 or more lines of treatment | 37.2 Months |
Primary
Real World Progression Free Survival
Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.
Time frame: From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)
Population: Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Real World Progression Free Survival | Overall | 18.8 Months |
| Palbociclib + Endocrine Therapy | Real World Progression Free Survival | 1 line of treatment | 21.0 Months |
| Palbociclib + Endocrine Therapy | Real World Progression Free Survival | 2 or more lines of treatment | 13.2 Months |
Primary
Real-World Tumor Response Rate
Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.
Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | Real-World Tumor Response Rate | Overall | 30.6 Percentage of participants |
| Palbociclib + Endocrine Therapy | Real-World Tumor Response Rate | 1 Line of treatment | 33.7 Percentage of participants |
| Palbociclib + Endocrine Therapy | Real-World Tumor Response Rate | 2 or more lines of treatment | 22.2 Percentage of participants |