Breast Cancer Metastatic
Conditions
Keywords
human epidermal growth factor receptor 2 negative (HER2-), hormone receptor positive (HR+), advanced breast cancer (ABC), metastatic breast cancer (MBC)
Brief summary
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Physician inclusion criteria: * Oncologist or gynecologist. * Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria. * Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period. Patient inclusion criteria: * HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease. * Received palbociclib as a first line therapy. * No prior or current enrolment in an interventional clinical trial for ABC/MBC. * Minimum of six months of follow up data since palbociclib initiation. Physician
Exclusion criteria
* Qualified less than 2 years ago or more than 35 years ago. * Participated in observational research for ABC/MBC in the last 3 months. * Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Rate at Month 6 | Month 6 (from the data collected and observed retrospectively for approximately 22 months) | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. |
| Progression Free Rate at Month 12 | Month 12 (from the data collected and observed retrospectively for approximately 22 months) | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. |
| Time From Palbociclib Initiation to Complete Response | From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | CR was defined as complete resolution of all visible disease per the treating physicians opinion. |
| Progression Free Rate at Month 18 | Month 18 (from the data collected and observed retrospectively for approximately 22 months) | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. |
| Progression Free Rate at Month 24 | Month 24 (from the data collected and observed retrospectively for approximately 22 months) | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. |
| Objective Response Rate | From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. |
| Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation | 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) | Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate. |
| Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation | 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) | Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate. |
| Clinical Benefit Rate | From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored. |
| Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib | From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. |
| Survival Rate at Month 6 | Month 6 (from the data collected and observed retrospectively for approximately 22 months) | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. |
| Survival Rate at Month 12 | Month 12 (from the data collected and observed retrospectively for approximately 22 months) | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. |
| Survival Rate at Month 18 | Month 18 (from the data collected and observed retrospectively for approximately 22 months) | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. |
| Survival Rate at Month 24 | Month 24 (from the data collected and observed retrospectively for approximately 22 months) | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. |
| Time From Palbociclib Initiation to Initial Response Recorded | From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. |
| Time From Palbociclib Initiation to Partial Response | From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. |
| Follow-up Time Since Palbociclib Initiation | From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
| Number of Participants With Supportive Therapies | From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | Number of participants who received supportive therapies during palbociclib treatment were reported. |
| Duration of Ongoing Palbociclib Treatment | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
| Duration of Discontinued Palbociclib Treatment | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
| Number of Participants According to Therapies Received Post Palbociclib Treatment | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | Number of participants who received therapies post palbociclib treatment were reported. |
| Time From Palbociclib Initiation to First Dose Reduction | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
| Duration of Dose Interruption | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
| Duration of Cycle Delays | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | — |
Countries
Argentina, United Kingdom
Participant flow
Recruitment details
Participants with hormone receptor (HR) positive/Human Epidermal Growth Factor Receptor 2 (HER2) negative advanced or metastatic breast cancer who received palbociclib in combination with aromatase inhibitor or fulvestrant as first-line therapy were observed. Data was collected retrospectively from participants medical records and evaluated over approximately 22 months of this study.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib + Aromatase Inhibitor Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | 574 |
| Palbociclib + Fulvestrant Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. | 273 |
| Total | 847 |
Baseline characteristics
| Characteristic | Total | Palbociclib + Fulvestrant | Palbociclib + Aromatase Inhibitor | — |
|---|---|---|---|---|
| Age at Advanced Breast Cancer (ABC)/Metastatic Breast Cancer (mBC) Diagnosis | 59.7 Years STANDARD_DEVIATION 11.2 | 58.3 Years STANDARD_DEVIATION 10 | 60.4 Years STANDARD_DEVIATION 11.7 | — |
| Age at Initial Breast Cancer Diagnosis | 57.2 Years STANDARD_DEVIATION 11.5 | 55.2 Years STANDARD_DEVIATION 10 | 58.1 Years STANDARD_DEVIATION 12 | — |
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 11.1 | 58.3 Years STANDARD_DEVIATION 10.2 | 60.9 Years STANDARD_DEVIATION 11.4 | — |
| Duration of adjuvant endocrine therapy | 31.2 Months STANDARD_DEVIATION 25 | 24.3 Months STANDARD_DEVIATION 22.4 | 40.7 Months STANDARD_DEVIATION 25.4 | — |
| Number of Participants According to Diagnosis for Which Palbociclib Combination was Prescribed | 847 Participants | 273 Participants | 574 Participants | — |
| Number of Participants According to Different Sites of Metastases Bone | 514 Participants | 140 Participants | 374 Participants | — |
| Number of Participants According to Different Sites of Metastases Brain | 10 Participants | 2 Participants | 8 Participants | — |
| Number of Participants According to Different Sites of Metastases Liver | 121 Participants | 32 Participants | 89 Participants | — |
| Number of Participants According to Different Sites of Metastases Lung | 210 Participants | 54 Participants | 156 Participants | — |
| Number of Participants According to Different Sites of Metastases Lymph node | 188 Participants | 43 Participants | 145 Participants | — |
| Number of Participants According to Different Sites of Metastases Non-visceral disease | 383 Participants | 119 Participants | 264 Participants | — |
| Number of Participants According to Different Sites of Metastases Other | 7 Participants | 3 Participants | 4 Participants | — |
| Number of Participants According to Different Sites of Metastases Ovary | 9 Participants | 6 Participants | 3 Participants | — |
| Number of Participants According to Different Sites of Metastases Skin/soft tissue | 127 Participants | 40 Participants | 87 Participants | — |
| Number of Participants According to Different Sites of Metastases Visceral disease | 305 Participants | 84 Participants | 221 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 213 Participants | 59 Participants | 154 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 417 Participants | 110 Participants | 307 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2 | 146 Participants | 43 Participants | 103 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 3 | 38 Participants | 32 Participants | 6 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 4 | 31 Participants | 28 Participants | 3 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Unknown | 2 Participants | 1 Participants | 1 Participants | — |
| Number of Participants According to Family History of Breast Cancer No | 614 Participants | 193 Participants | 421 Participants | — |
| Number of Participants According to Family History of Breast Cancer Unknown | 61 Participants | 23 Participants | 38 Participants | — |
| Number of Participants According to Family History of Breast Cancer Yes | 172 Participants | 57 Participants | 115 Participants | — |
| Number of Participants According to Menopause Status at Palbociclib Initiation Menopause Induced by LHRH Suppression | 48 Participants | 15 Participants | 33 Participants | — |
| Number of Participants According to Menopause Status at Palbociclib Initiation Menopause Induced by Surgery | 59 Participants | 10 Participants | 49 Participants | — |
| Number of Participants According to Menopause Status at Palbociclib Initiation Natural Menopause | 717 Participants | 234 Participants | 483 Participants | — |
| Number of Participants According to Menopause Status at Palbociclib Initiation Perimenopausal | 14 Participants | 12 Participants | 2 Participants | — |
| Number of Participants According to Menopause Status at Palbociclib Initiation Premenopausal | 9 Participants | 2 Participants | 7 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 0 | 1 Participants | 1 Participants | 0 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 1 | 32 Participants | 11 Participants | 21 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 2 | 202 Participants | 91 Participants | 111 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 3a | 230 Participants | 144 Participants | 86 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 3b | 46 Participants | 5 Participants | 41 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 3c | 22 Participants | 1 Participants | 21 Participants | — |
| Number of Participants According to Stage of Initial Breast Cancer Stage 4 | 314 Participants | 20 Participants | 294 Participants | — |
| Number of Participants According to Type of Insurance Plan Argentina-PrivadoPrepagas | 179 Participants | 56 Participants | 123 Participants | — |
| Number of Participants According to Type of Insurance Plan Argentina-Seguridad Social | 234 Participants | 58 Participants | 176 Participants | — |
| Number of Participants According to Type of Insurance Plan Argentina-Servicio de Salud Publico | 56 Participants | 5 Participants | 51 Participants | — |
| Number of Participants According to Type of Insurance Plan Chile-FONASA (El Fondo Nacional de Salud) | 6 Participants | 5 Participants | 1 Participants | — |
| Number of Participants According to Type of Insurance Plan Chile-ISAPRE (Instituciones de Salud Previsional) | 2 Participants | 0 Participants | 2 Participants | — |
| Number of Participants According to Type of Insurance Plan Colombia-Contributive regime (POS-C) | 139 Participants | 82 Participants | 57 Participants | — |
| Number of Participants According to Type of Insurance Plan Colombia-Special regime (i.e. teacher or military) | 23 Participants | 22 Participants | 1 Participants | — |
| Number of Participants According to Type of Insurance Plan Colombia-Subsidized regime (POS-S) | 38 Participants | 16 Participants | 22 Participants | — |
| Number of Participants According to Type of Insurance Plan Colombia-Unknown | 6 Participants | 1 Participants | 5 Participants | — |
| Number of Participants According to Type of Insurance Plan Costa rica/Panama-Aseguradora privada | 5 Participants | 0 Participants | 5 Participants | — |
| Number of Participants According to Type of Insurance Plan Costa rica/Panama-CSS (Caja de seguridad social) | 36 Participants | 8 Participants | 28 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-Aseguradora privada | 59 Participants | 6 Participants | 53 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-Aseguradoras privadas | 30 Participants | 6 Participants | 24 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-IMSS | 14 Participants | 4 Participants | 10 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-ISSSTE | 7 Participants | 0 Participants | 7 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico- PEMEX | 7 Participants | 3 Participants | 4 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-Sedena | 1 Participants | 1 Participants | 0 Participants | — |
| Number of Participants According to Type of Insurance Plan Mexico-SSA | 5 Participants | 0 Participants | 5 Participants | — |
| Number of Participants Prescribed Palbociclib (Aromatase Inhibitor or Fulvestrant at First Line) | 847 Participants | 273 Participants | 574 Participants | — |
| Number of Participants who Received Radiotherapy or Surgery Radiotherapy | 377 Participants | 200 Participants | 177 Participants | — |
| Number of Participants who Received Radiotherapy or Surgery Surgery | 385 Participants | 195 Participants | 190 Participants | — |
| Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis Adjuvant Chemotherapy | 268 Participants | 138 Participants | 130 Participants | — |
| Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis Adjuvant endocrine therapy | 423 Participants | 245 Participants | 178 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Bradyarrhythmias | 3 Participants | 2 Participants | 1 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Cerebrovascular disease | 10 Participants | 3 Participants | 7 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Chronic pulmonary disease | 23 Participants | 11 Participants | 12 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Congestive heart failure | 13 Participants | 8 Participants | 5 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Connective tissue disease | 1 Participants | 0 Participants | 1 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Dementia | 7 Participants | 2 Participants | 5 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Depression | 85 Participants | 35 Participants | 50 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Diabetes with end organ damage | 13 Participants | 1 Participants | 12 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Diabetes without end organ damage | 135 Participants | 46 Participants | 89 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Electrolyte abnormalities | 2 Participants | 0 Participants | 2 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Hypertension | 321 Participants | 94 Participants | 227 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Long QT syndrome | 1 Participants | 0 Participants | 1 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Mild liver disease | 15 Participants | 8 Participants | 7 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Moderate to severe renal disease | 28 Participants | 23 Participants | 5 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Myelosuppression | 2 Participants | 0 Participants | 2 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Myocardial infarction | 2 Participants | 1 Participants | 1 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation None | 363 Participants | 106 Participants | 257 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Other | 30 Participants | 9 Participants | 21 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Peptic ulcer disease | 27 Participants | 9 Participants | 18 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Peripheral vascular disease | 17 Participants | 3 Participants | 14 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Unknown | 13 Participants | 4 Participants | 9 Participants | — |
| Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation Unstable angina | 4 Participants | 2 Participants | 2 Participants | — |
| Number of Participants With De novo and Recurrent Breast Cancer De Novo | 382 Participants | 26 Participants | 356 Participants | — |
| Number of Participants With De novo and Recurrent Breast Cancer Recurrent | 465 Participants | 247 Participants | 218 Participants | — |
| Number of Participants With Metastases to Lymph Nodes Lymph nodes, Distal | 90 Participants | 31 Participants | 59 Participants | — |
| Number of Participants With Metastases to Lymph Nodes Lymph nodes, Regional | 97 Participants | 12 Participants | 85 Participants | — |
| Number of Participants With Positive Biomarker Status Androgen receptor | 102 Participants | 71 Participants | 31 Participants | — |
| Number of Participants With Positive Biomarker Status BRCA1 | 70 Participants | 59 Participants | 11 Participants | — |
| Number of Participants With Positive Biomarker Status BRCA2 | 63 Participants | 58 Participants | 5 Participants | — |
| Number of Participants With Positive Biomarker Status ESR1 mutation | 36 Participants | 36 Participants | 0 Participants | — |
| Race/Ethnicity, Customized African American | 1 Participants | 0 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Afro-Caribbean | 9 Participants | 6 Participants | 3 Participants | — |
| Race/Ethnicity, Customized Asian-Indian subcontinent | 1 Participants | 0 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Asian - other | 1 Participants | 1 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Black | 3 Participants | 3 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Chinese | 1 Participants | 1 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Hispanic/Latino | 528 Participants | 180 Participants | 348 Participants | — |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Mixed race | 40 Participants | 9 Participants | 31 Participants | — |
| Race/Ethnicity, Customized Native American | 8 Participants | 3 Participants | 5 Participants | — |
| Race/Ethnicity, Customized Other | 11 Participants | 4 Participants | 7 Participants | — |
| Race/Ethnicity, Customized Prefer not to answer | 7 Participants | 5 Participants | 2 Participants | — |
| Race/Ethnicity, Customized White/Caucasian | 236 Participants | 61 Participants | 175 Participants | — |
| Sex: Female, Male Female | 847 Participants | 273 Participants | 574 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | — |
| Time from ABC/mBC Diagnosis to Palbociclib Initiation | 1.7 Months | 1.4 Months | 1.8 Months | — |
| Time From Advanced/Metastatic Diagnosis to Palbociclib Initiation | 1.7 Months | 1.4 Months | 1.8 Months | — |
| Time From Initial Breast Cancer Diagnosis to ABC/mBC Diagnosis | 39.2 Months | 25.1 Months | 58.0 Months | — |
| Time From Initial Breast Cancer Diagnosis to Palbociclib Initiation | 15.3 Months | 27.0 Months | 6.0 Months | — |
| Time From Regimen Completion of Adjuvant Therapy to Diagnosis of ABC/mBC | — | — | — | — Months |
| Time Since end of Adjuvant Treatment | — | — | — | — Months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 54 / 574 | 15 / 273 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.
Time frame: From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Clinical Benefit Rate | 94.2 Percentage of participants |
| Palbociclib + Fulvestrant | Clinical Benefit Rate | 95.2 Percentage of participants |
Primary
Duration of Cycle Delays
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Duration of Cycle Delays | 24.5 Days |
| Palbociclib + Fulvestrant | Duration of Cycle Delays | 21.0 Days |
Primary
Duration of Discontinued Palbociclib Treatment
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Duration of Discontinued Palbociclib Treatment | 8.0 Months |
| Palbociclib + Fulvestrant | Duration of Discontinued Palbociclib Treatment | 5.0 Months |
Primary
Duration of Dose Interruption
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Duration of Dose Interruption | 14.0 Days |
| Palbociclib + Fulvestrant | Duration of Dose Interruption | 21.0 Days |
Primary
Duration of Ongoing Palbociclib Treatment
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Duration of Ongoing Palbociclib Treatment | 11.2 Months |
| Palbociclib + Fulvestrant | Duration of Ongoing Palbociclib Treatment | 8.5 Months |
Primary
Follow-up Time Since Palbociclib Initiation
Time frame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Follow-up Time Since Palbociclib Initiation | 12.7 Months |
| Palbociclib + Fulvestrant | Follow-up Time Since Palbociclib Initiation | 10.7 Months |
Primary
Number of Participants According to Therapies Received Post Palbociclib Treatment
Number of participants who received therapies post palbociclib treatment were reported.
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Gemcitabine/GEMZAR | 4 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Docetaxel/TAXOTERE | 6 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Nab Paclitaxel/ABRAXANE | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/FASLODEX,Exemestane/AROMASIN,Methotrexate | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Other | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Docetaxel/TAXOTERE,Capecitabine / XELODA | 3 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL | 13 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andLetrozole/ FEMARA | 4 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Capecitabine / XELODA | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Doxorubicin/ADRIAMYCIN | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Doxorubicin/ ADRIAMYCIN,Cyclophosphamide/CYTOXAN | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/FASLODEX,Methotrexate | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Gemcitabine/ GEMZAR | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Doxorubicin/ADRIAMYCIN,Cyclophosphamide/CYTOXAN | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE and Anastrozole /ARIMIDEX,Methotrexate | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Anastrozole/ARIMIDEX | 2 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/ IBRANCE and Exemestane / AROMASIN,Capecitabine/XELODA | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Everolimus/AFINITOR andExemestane/AROMASIN | 11 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib / IBRANCE and Fulvestrant/FASLODEX,Ixabepilone /IXEMPRA | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Letrozole/FEMARA | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Ribociclib / KISQALI and Exemestane / AROMASIN,Epirubicin /PHARMORUBICIN | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Exemestane/AROMASIN | 6 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Tamoxifen / NOLVADEX | 3 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Capecitabine/XELODA | 15 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Tamoxifen / NOLVADEX,Doxorubicin / ADRIAMYCIN | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Fulvestrant/FASLODEX | 16 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Toremifene / FARESTON | 1 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Tamoxifen/NOLVADEX,Methotrexate | 0 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | No treatment | 482 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib / IBRANCE and Fulvestrant/FASLODEX | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | No treatment | 188 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib / IBRANCE and Fulvestrant/FASLODEX | 34 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/FASLODEX,Exemestane/AROMASIN,Methotrexate | 2 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Letrozole/FEMARA | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/FASLODEX,Methotrexate | 7 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Tamoxifen/NOLVADEX,Methotrexate | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE andLetrozole/ FEMARA | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Anastrozole/ARIMIDEX | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Capecitabine/XELODA | 15 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Docetaxel/TAXOTERE | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Docetaxel/TAXOTERE,Capecitabine / XELODA | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Doxorubicin/ADRIAMYCIN | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Doxorubicin/ADRIAMYCIN,Cyclophosphamide/CYTOXAN | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Everolimus/AFINITOR andExemestane/AROMASIN | 7 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Exemestane/AROMASIN | 3 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Fulvestrant/FASLODEX | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Gemcitabine/GEMZAR | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Nab Paclitaxel/ABRAXANE | 2 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Other | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL | 4 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Capecitabine / XELODA | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Doxorubicin/ ADRIAMYCIN,Cyclophosphamide/CYTOXAN | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Paclitaxel/TAXOL,Gemcitabine/ GEMZAR | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/IBRANCE and Anastrozole /ARIMIDEX,Methotrexate | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib/ IBRANCE and Exemestane / AROMASIN,Capecitabine/XELODA | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Palbociclib / IBRANCE and Fulvestrant/FASLODEX,Ixabepilone /IXEMPRA | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Ribociclib / KISQALI and Exemestane / AROMASIN,Epirubicin /PHARMORUBICIN | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Tamoxifen / NOLVADEX | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Tamoxifen / NOLVADEX,Doxorubicin / ADRIAMYCIN | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Therapies Received Post Palbociclib Treatment | Toremifene / FARESTON | 0 Participants |
Primary
Number of Participants With Supportive Therapies
Number of participants who received supportive therapies during palbociclib treatment were reported.
Time frame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Participants could receive more than one supportive treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Bisphosphonates | 246 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Non-steroidal anti-inflammatory drugs | 232 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Opioid extended release | 100 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Anti-emetics | 53 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Anti-anxiety drugs | 85 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Anti-depressants | 43 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Opioid immediate release | 47 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Other supportive care | 35 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Antibiotics | 51 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Nutritional support | 46 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Granulocyte colony stimulating factors | 24 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Antifungals | 9 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Unknown | 2 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Red blood cell transfusion | 37 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Pruritus/rash treatments | 5 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Erythropoietin stimulating agents | 3 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Platelet transfusions | 7 Participants |
| Palbociclib + Aromatase Inhibitor | Number of Participants With Supportive Therapies | Antivirals | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Red blood cell transfusion | 11 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Bisphosphonates | 88 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Nutritional support | 68 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Non-steroidal anti-inflammatory drugs | 88 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Antivirals | 15 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Opioid extended release | 79 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Granulocyte colony stimulating factors | 7 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Anti-emetics | 19 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Pruritus/rash treatments | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Anti-anxiety drugs | 34 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Antifungals | 2 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Anti-depressants | 56 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Platelet transfusions | 4 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Opioid immediate release | 20 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Unknown | 2 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Other supportive care | 56 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Erythropoietin stimulating agents | 2 Participants |
| Palbociclib + Fulvestrant | Number of Participants With Supportive Therapies | Antibiotics | 19 Participants |
Primary
Objective Response Rate
Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Time frame: From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Objective Response Rate | 69.8 Percentage of participants |
| Palbociclib + Fulvestrant | Objective Response Rate | 67.3 Percentage of participants |
Primary
Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation
Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.
Time frame: 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation | 95.0 Percentage of participants |
| Palbociclib + Fulvestrant | Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation | 96.9 Percentage of participants |
Primary
Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation
Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Time frame: 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation | 83.0 Percentage of participants |
| Palbociclib + Fulvestrant | Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation | 88.8 Percentage of participants |
Primary
Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib
SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Time frame: From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib | 24.5 Percentage of participants |
| Palbociclib + Fulvestrant | Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib | 23.2 Percentage of participants |
Primary
Progression Free Rate at Month 12
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Time frame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Progression Free Rate at Month 12 | 80.9 Percentage of participants |
| Palbociclib + Fulvestrant | Progression Free Rate at Month 12 | 76.3 Percentage of participants |
Primary
Progression Free Rate at Month 18
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Time frame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Progression Free Rate at Month 18 | 68.8 Percentage of participants |
| Palbociclib + Fulvestrant | Progression Free Rate at Month 18 | 66.2 Percentage of participants |
Primary
Progression Free Rate at Month 24
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Time frame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Progression Free Rate at Month 24 | 60.9 Percentage of participants |
| Palbociclib + Fulvestrant | Progression Free Rate at Month 24 | 56.1 Percentage of participants |
Primary
Progression Free Rate at Month 6
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression 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; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Time frame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Progression Free Rate at Month 6 | 93.4 Percentage of participants |
| Palbociclib + Fulvestrant | Progression Free Rate at Month 6 | 91.3 Percentage of participants |
Primary
Survival Rate at Month 12
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time frame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Survival Rate at Month 12 | 95.0 Percentage of participants |
| Palbociclib + Fulvestrant | Survival Rate at Month 12 | 96.9 Percentage of participants |
Primary
Survival Rate at Month 18
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time frame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Survival Rate at Month 18 | 87.7 Percentage of participants |
| Palbociclib + Fulvestrant | Survival Rate at Month 18 | 91.2 Percentage of participants |
Primary
Survival Rate at Month 24
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time frame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Survival Rate at Month 24 | 83.0 Percentage of participants |
| Palbociclib + Fulvestrant | Survival Rate at Month 24 | 88.8 Percentage of participants |
Primary
Survival Rate at Month 6
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time frame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Survival Rate at Month 6 | 98.9 Percentage of participants |
| Palbociclib + Fulvestrant | Survival Rate at Month 6 | 99.6 Percentage of participants |
Primary
Time From Palbociclib Initiation to Complete Response
CR was defined as complete resolution of all visible disease per the treating physicians opinion.
Time frame: From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Time From Palbociclib Initiation to Complete Response | 4.5 Months |
| Palbociclib + Fulvestrant | Time From Palbociclib Initiation to Complete Response | 4.0 Months |
Primary
Time From Palbociclib Initiation to First Dose Reduction
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Time From Palbociclib Initiation to First Dose Reduction | 3.7 Months |
| Palbociclib + Fulvestrant | Time From Palbociclib Initiation to First Dose Reduction | 3.4 Months |
Primary
Time From Palbociclib Initiation to Initial Response Recorded
CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Time frame: From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Time From Palbociclib Initiation to Initial Response Recorded | 3.2 Months |
| Palbociclib + Fulvestrant | Time From Palbociclib Initiation to Initial Response Recorded | 3.0 Months |
Primary
Time From Palbociclib Initiation to Partial Response
PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Time frame: From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Aromatase Inhibitor | Time From Palbociclib Initiation to Partial Response | 3.2 Months |
| Palbociclib + Fulvestrant | Time From Palbociclib Initiation to Partial Response | 3.2 Months |