Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors, Cancer of Breast
Conditions
Keywords
Hormone receptor positive / human epidermal growth factor 2 negative (HR+/HER2-), Advanced Breast Cancer, Metastatic Breast Cancer, Palbociclib, aromatase inhibitor, fulvestrant
Brief summary
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in India. There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
Interventions
DRUGPalbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment
DRUGPalbociclib plus hormonal treatment - second line treatment
Palbociclib plus hormonal treatment
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease * Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy * Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant * No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer * Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation
Exclusion criteria
* Cancers other than breast cancer * Male breast cancer * Visceral crisis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to the Starting Dose of Palbociclib | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants according to their starting dose (125 milligrams per day \[mg/day\], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Duration of Treatment | From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants Who Had Any Palbociclib Dose Reduction | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants Who Had Any Interruption in Palbociclib Treatment | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants Who Had Any Delays in Palbociclib Treatment | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Reasons for Treatment Discontinuation | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Reasons for Change in Treatment | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Progression Free Survival | From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Objective Response Rate (ORR) | From index date to CR/PR, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants Who Died | From index date to death, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Overall Survival (OS) | From index date to death due to any cause, (from Dec 2016 to May 2021 [approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Biomarker Status | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants With Family History of Breast Cancer | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Duration From Breast Cancer Diagnosis to Palbociclib Treatment | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Stages of Breast Cancer | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Node Status | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Menopausal Status | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market. |
| Number of Participants According to Metastatic Sites | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases. |
| Number of Participants According to de Novo and Recurrent Disease | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Therapies Received for Early Breast Cancer | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Time Since End of Adjuvant Treatment | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Duration of Supportive Treatments for ABC/MBC | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
| Number of Participants According to Reasons for Regimen Change | From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study) | Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. |
Countries
India
Participant flow
Recruitment details
Data of participants diagnosed with hormone receptor positive (HR+) /human epidermal growth factor receptor 2 negative (HER2-) advanced/metastatic breast cancer (ABC/MBC), who received palbociclib combined with aromatase inhibitor in menopausal state as initial endocrine therapy in MBC or with fulvestrant after progression on prior endocrine therapy were observed.
Pre-assignment details
This retrospective observational study used medical records of participants from 6 oncology hospitals within a period of Dec 2016 to May 2021 (approximately 4.5 years). Available data was evaluated in 9 months of this retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib: 1st Line Therapy Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study. | 105 |
| Palbociclib: 2nd Line Therapy Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study. | 45 |
| Total | 150 |
Baseline characteristics
| Characteristic | Palbociclib: 1st Line Therapy | Palbociclib: 2nd Line Therapy | Total |
|---|---|---|---|
| Age, Customized Greater than (>) 65 years | 39 Participants | 13 Participants | 52 Participants |
| Age, Customized Less than or equal to (<=) 65 years | 66 Participants | 32 Participants | 98 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 105 Participants | 45 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 105 | 3 / 45 |
| other Total, other adverse events | 2 / 105 | 0 / 45 |
| serious Total, serious adverse events | 4 / 105 | 0 / 45 |
Outcome results
Primary
Duration From Breast Cancer Diagnosis to Palbociclib Treatment
Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Duration From Breast Cancer Diagnosis to Palbociclib Treatment | 8.69 Months | Standard Deviation 26.12 |
| Palbociclib: 2nd Line Therapy | Duration From Breast Cancer Diagnosis to Palbociclib Treatment | 45.50 Months | Standard Deviation 43.53 |
Primary
Duration of Supportive Treatments for ABC/MBC
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Duration of Supportive Treatments for ABC/MBC | NA Months |
| Palbociclib: 2nd Line Therapy | Duration of Supportive Treatments for ABC/MBC | NA Months |
Primary
Duration of Treatment
Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Duration of Treatment | 15.08 Months |
| Palbociclib: 2nd Line Therapy | Duration of Treatment | 11.63 Months |
Primary
Number of Participants According to Biomarker Status
Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Biomarker Status | NA Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Biomarker Status | NA Participants |
Primary
Number of Participants According to de Novo and Recurrent Disease
Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to de Novo and Recurrent Disease | NA Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to de Novo and Recurrent Disease | NA Participants |
Primary
Number of Participants According to Menopausal Status
Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Menopausal Status | Induced | 16 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Menopausal Status | Natural | 88 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Menopausal Status | Data not available | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Menopausal Status | Induced | 16 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Menopausal Status | Natural | 29 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Menopausal Status | Data not available | 0 Participants |
Primary
Number of Participants According to Metastatic Sites
Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Bone | 62 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Lung | 28 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Liver | 14 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Lymph nodes | 16 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Others | 7 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Metastatic Sites | Data not available | 12 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Others | 4 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Bone | 28 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Lymph nodes | 6 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Lung | 16 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Data not available | 3 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Metastatic Sites | Liver | 7 Participants |
Primary
Number of Participants According to Node Status
Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Node Status | Distal | 6 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Node Status | Regional nodes | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Node Status | Regional nodes | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Node Status | Distal | 1 Participants |
Primary
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 1 | 65 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 3 | 0 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 2 | 6 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Data not available | 34 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 2 | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 1 | 33 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Data not available | 6 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 3 | 1 Participants |
Primary
Number of Participants According to Reasons for Change in Treatment
Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Reduced | 12 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Interrupted (temporarily stopped during a dose cycle) | 9 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Other reasons | 5 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Cycle delay (the next cycle is pushed back) | 7 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Resumed following interruption or cycle delay | 9 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Combination partner therapy continued | 17 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Change in Treatment | Side effects/toxicity | 10 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Combination partner therapy continued | 3 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Side effects/toxicity | 3 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Other reasons | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Reduced | 4 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Resumed following interruption or cycle delay | 3 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Dose Interrupted (temporarily stopped during a dose cycle) | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Change in Treatment | Cycle delay (the next cycle is pushed back) | 1 Participants |
Primary
Number of Participants According to Reasons for Regimen Change
Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Regimen Change | NA Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Regimen Change | NA Participants |
Primary
Number of Participants According to Reasons for Treatment Discontinuation
Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Treatment Discontinuation | Increased transaminases | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Reasons for Treatment Discontinuation | Cardiomyopathy | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Treatment Discontinuation | Increased transaminases | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Reasons for Treatment Discontinuation | Cardiomyopathy | 0 Participants |
Primary
Number of Participants According to Stages of Breast Cancer
Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage II | 5 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage IV | 70 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage IIIa | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Stages of Breast Cancer | Data not available | 24 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage I | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Stages of Breast Cancer | Data not available | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage I | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage II | 12 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage IIIa | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Stages of Breast Cancer | Stage IV | 31 Participants |
Primary
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-anxiety | 3 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Opioid extended release | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Antibiotics | 5 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Opioid immediate release | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-depressants | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Non-steroidal anti-inflammatory drugs | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Bisphosphonates | 8 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Other supportive care | 36 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-emetics | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | NA | 50 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Nutritional support | 37 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | NA | 36 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Nutritional support | 7 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Bisphosphonates | 2 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Antibiotics | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-anxiety | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-depressants | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Anti-emetics | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Opioid extended release | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Opioid immediate release | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Non-steroidal anti-inflammatory drugs | 0 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis | Other supportive care | 3 Participants |
Primary
Number of Participants According to Therapies Received for Early Breast Cancer
Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Adjuvant chemotherapy | 4 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Adjuvant endocrine therapy | 14 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Neoadjuvant treatment | 6 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Radiotherapy | 20 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Surgery | 13 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Data not available | 69 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Surgery | 26 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Adjuvant chemotherapy | 8 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Radiotherapy | 26 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Adjuvant endocrine therapy | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Data not available | 9 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to Therapies Received for Early Breast Cancer | Neoadjuvant treatment | 11 Participants |
Primary
Number of Participants According to the Starting Dose of Palbociclib
Number of participants according to their starting dose (125 milligrams per day \[mg/day\], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | 125mg/day | 99 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | 100mg/day | 1 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | Data not available | 5 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | 125mg/day | 43 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | 100mg/day | 2 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants According to the Starting Dose of Palbociclib | Data not available | 0 Participants |
Primary
Number of Participants Who Died
Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date to death, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants Who Died | 8 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants Who Died | 3 Participants |
Primary
Number of Participants Who Had Any Delays in Palbociclib Treatment
Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants Who Had Any Delays in Palbociclib Treatment | 7 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants Who Had Any Delays in Palbociclib Treatment | 1 Participants |
Primary
Number of Participants Who Had Any Interruption in Palbociclib Treatment
Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants Who Had Any Interruption in Palbociclib Treatment | 9 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants Who Had Any Interruption in Palbociclib Treatment | 1 Participants |
Primary
Number of Participants Who Had Any Palbociclib Dose Reduction
Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants Who Had Any Palbociclib Dose Reduction | Dose reduced to 100 mg | 13 Participants |
| Palbociclib: 1st Line Therapy | Number of Participants Who Had Any Palbociclib Dose Reduction | Dose reduced to 75 mg | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants Who Had Any Palbociclib Dose Reduction | Dose reduced to 100 mg | 1 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants Who Had Any Palbociclib Dose Reduction | Dose reduced to 75 mg | 0 Participants |
Primary
Number of Participants With Family History of Breast Cancer
Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Number of Participants With Family History of Breast Cancer | 4 Participants |
| Palbociclib: 2nd Line Therapy | Number of Participants With Family History of Breast Cancer | 0 Participants |
Primary
Objective Response Rate (ORR)
The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date to CR/PR, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Objective Response Rate (ORR) | 63.81 Percentage of participants |
| Palbociclib: 2nd Line Therapy | Objective Response Rate (ORR) | 77.78 Percentage of participants |
Primary
Overall Survival (OS)
OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date to death due to any cause, (from Dec 2016 to May 2021 [approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Overall Survival (OS) | NA Months |
| Palbociclib: 2nd Line Therapy | Overall Survival (OS) | NA Months |
Primary
Progression Free Survival
Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Progression Free Survival | 31.97 Months |
| Palbociclib: 2nd Line Therapy | Progression Free Survival | 22.33 Months |
Primary
Time Since End of Adjuvant Treatment
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib: 1st Line Therapy | Time Since End of Adjuvant Treatment | NA Months |
| Palbociclib: 2nd Line Therapy | Time Since End of Adjuvant Treatment | NA Months |