Breast Cancer
Conditions
Brief summary
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented diagnosis of HR+/HER2- mBC 2. Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date 3. Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes
Exclusion criteria
1. Enrollment in an interventional clinical trial during the study period 2. Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting 3. Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. |
| Number of Participants According to Reasons for Treatment Discontinuation | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure. |
| Real-World Duration of Treatment (rwDOT) | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. |
| Percentage of Participants With Provider Documented Disease Progression | From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure. |
| Real-World Time to Tumor Progression (rwTTP) | From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis. |
| Real-World Progression-Free Survival (rwPFS) | From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis. |
| Time to Next Treatment (TTNT) From Index Treatment | From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. |
| Time to Chemotherapy | From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Treatment for Advanced Metastatic Breast Cancer | From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) | The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure. |
| Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer | Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study) | Percentage of participants with prior adjuvant hormonal treatment for breast cancer were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. |
| Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Quarter(Q)1 2015,Q2 2015,Q3 2015,Q4 2015,Q1 2016,Q2 2016,Q3 2016,Q4 2016,Q1 2017,Q2 2017,Q3 2017,Q4 2017,Q1 2018,Q2 2018,Q3 2018,Q4 2018,Q1 2019,Q2 2019,Q3 2019,Q4 2019(data was retrieved and observed during 2.5 years of this retrospective study) | Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure. |
| Percentage of Participants With Change in Dose | From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study) | The percentage of participants with dose change for index treatment were reported in this outcome measure. |
| Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment | At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study) | The percentage of participants classified according to the dosing strength of Palbociclib and Fulvestrant as their index treatment were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. |
Countries
United States
Participant flow
Recruitment details
Data for participants diagnosed with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC), who initiated first line treatment with palbociclib in combination with fulvestrant between 01-February-2016 to 31-December-2019 were observed retrospectively. To allow minimum follow-up period of 6 months, participants were followed until 30 June 2020, last participant record or date of death, whichever occurred first.
Pre-assignment details
Data was retrieved from electronic healthcare record (EHR) and available data was evaluated over 2.5 years of this retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib + Fulvestrant Participants who initiated palbociclib in combination with fulvestrant as first line therapy for HR+/HER2- MBC during the period 01-February-2016 to 31-December-2019 were included in this retrospective observational study. Participants were followed up until 30-Jun-2020. | 317 |
| Total | 317 |
Baseline characteristics
| Characteristic | Palbociclib + Fulvestrant |
|---|---|
| Age, Continuous | 67.3 Years |
| Age, Customized 18-50 | 22 Participants |
| Age, Customized 51-70 | 174 Participants |
| Age, Customized More than (>) 70 | 121 Participants |
| Body Mass Index (BMI) at Index Date | 28.8 Kilogram per square meter STANDARD_DEVIATION 6.9 |
| Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status Negative | 27 Participants |
| Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status Not documented | 286 Participants |
| Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status Positive | 4 Participants |
| Number of Participants According to Comorbidities Atrial fibrillation | 6 Participants |
| Number of Participants According to Comorbidities Cerebrovascular disease | 3 Participants |
| Number of Participants According to Comorbidities Chronic pulmonary disease | 15 Participants |
| Number of Participants According to Comorbidities Congestive heart failure | 4 Participants |
| Number of Participants According to Comorbidities Connective tissue disease | 3 Participants |
| Number of Participants According to Comorbidities Dementia | 2 Participants |
| Number of Participants According to Comorbidities Depression | 29 Participants |
| Number of Participants According to Comorbidities Diabetes with end organ damage | 10 Participants |
| Number of Participants According to Comorbidities Diabetes without end organ damage | 38 Participants |
| Number of Participants According to Comorbidities Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS) | 1 Participants |
| Number of Participants According to Comorbidities Hypertension | 112 Participants |
| Number of Participants According to Comorbidities Hypotension | 47 Participants |
| Number of Participants According to Comorbidities Infection | 1 Participants |
| Number of Participants According to Comorbidities Long QT syndrome (drug induced) | 1 Participants |
| Number of Participants According to Comorbidities Mild liver disease | 2 Participants |
| Number of Participants According to Comorbidities Moderate to severe renal disease | 9 Participants |
| Number of Participants According to Comorbidities Myocardial infarction | 3 Participants |
| Number of Participants According to Comorbidities Peptic ulcer disease | 2 Participants |
| Number of Participants According to Comorbidities Peripheral vascular disease | 1 Participants |
| Number of Participants According to Comorbidities Stroke | 3 Participants |
| Number of Participants According to Comorbidities Tachycardia | 1 Participants |
| Number of Participants According to Comorbidities Venous thromboembolism (pulmonary embolism or deep vein thrombosis) | 13 Participants |
| Number of Participants According to Count of Metastatic Sites 1 | 178 Participants |
| Number of Participants According to Count of Metastatic Sites 2 | 83 Participants |
| Number of Participants According to Count of Metastatic Sites 3 | 44 Participants |
| Number of Participants According to Count of Metastatic Sites 4+ | 12 Participants |
| Number of Participants According to Disease-Free Interval Less than (<) 12 months | 178 Participants |
| Number of Participants According to Disease-Free Interval More than or equal to (>=) 12 months | 91 Participants |
| Number of Participants According to Disease Histology Ductal | 142 Participants |
| Number of Participants According to Disease Histology Lobular | 27 Participants |
| Number of Participants According to Disease Histology No information | 145 Participants |
| Number of Participants According to Disease Histology Other | 3 Participants |
| Number of Participants According to Distant Metastatic Sites Bone (multiple) | 181 Participants |
| Number of Participants According to Distant Metastatic Sites Bone (single) | 47 Participants |
| Number of Participants According to Distant Metastatic Sites Brain | 8 Participants |
| Number of Participants According to Distant Metastatic Sites Liver (multiple) | 43 Participants |
| Number of Participants According to Distant Metastatic Sites Liver (single) | 19 Participants |
| Number of Participants According to Distant Metastatic Sites Lung (multiple) | 41 Participants |
| Number of Participants According to Distant Metastatic Sites Lung (pleural effusion) | 36 Participants |
| Number of Participants According to Distant Metastatic Sites Lung (single) | 28 Participants |
| Number of Participants According to Distant Metastatic Sites Lymph nodes (distant) | 43 Participants |
| Number of Participants According to Distant Metastatic Sites Lymph nodes (regional) | 32 Participants |
| Number of Participants According to Distant Metastatic Sites Other | 47 Participants |
| Number of Participants According to Distant Metastatic Sites Ovary | 1 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 73 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 107 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 26 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status More than or equal to (>=) 3 | 5 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Not documented | 106 Participants |
| Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status Negative | 7 Participants |
| Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status Not documented | 309 Participants |
| Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status Positive | 1 Participants |
| Number of Participants According to Family History of Cancer No/no information | 111 Participants |
| Number of Participants According to Family History of Cancer Yes | 206 Participants |
| Number of Participants According to Menopausal Status No information | 20 Participants |
| Number of Participants According to Menopausal Status Peri-menopausal | 1 Participants |
| Number of Participants According to Menopausal Status Post-menopausal | 287 Participants |
| Number of Participants According to Menopausal Status Pre-menopausal | 9 Participants |
| Number of Participants According to Next Generation Sequencing (NGS) Status Negative | 5 Participants |
| Number of Participants According to Next Generation Sequencing (NGS) Status No information | 305 Participants |
| Number of Participants According to Next Generation Sequencing (NGS) Status Positive | 7 Participants |
| Number of Participants According to Smoking history Current smoker | 18 Participants |
| Number of Participants According to Smoking history Former smoker | 81 Participants |
| Number of Participants According to Smoking history Never smoked | 111 Participants |
| Number of Participants According to Smoking history No information | 107 Participants |
| Number of Participants According to Stage at Diagnosis No information | 149 Participants |
| Number of Participants According to Stage at Diagnosis Stage I | 0 Participants |
| Number of Participants According to Stage at Diagnosis Stage IA | 18 Participants |
| Number of Participants According to Stage at Diagnosis Stage IB | 3 Participants |
| Number of Participants According to Stage at Diagnosis Stage IIA | 33 Participants |
| Number of Participants According to Stage at Diagnosis Stage IIB | 31 Participants |
| Number of Participants According to Stage at Diagnosis Stage IIIA | 26 Participants |
| Number of Participants According to Stage at Diagnosis Stage IIIB | 4 Participants |
| Number of Participants According to Stage at Diagnosis Stage IIIC | 12 Participants |
| Number of Participants According to Stage at Diagnosis Stage IV | 41 Participants |
| Number of Participants According to Visceral/non-Visceral Status Asymptomatic visceral disease | 105 Participants |
| Number of Participants According to Visceral/non-Visceral Status Bone only | 117 Participants |
| Number of Participants According to Visceral/non-Visceral Status Non-visceral disease | 27 Participants |
| Number of Participants According to Visceral/non-Visceral Status Not documented | 14 Participants |
| Number of Participants According to Visceral/non-Visceral Status Other | 5 Participants |
| Number of Participants According to Visceral/non-Visceral Status Symptomatic visceral disease | 49 Participants |
| Race/Ethnicity, Customized Black or African American | 27 Participants |
| Race/Ethnicity, Customized Not documented | 41 Participants |
| Race/Ethnicity, Customized Other | 10 Participants |
| Race/Ethnicity, Customized White | 239 Participants |
| Sex: Female, Male Female | 312 Participants |
| Sex: Female, Male Male | 5 Participants |
| Time Since Initial BC Diagnosis | 380.6 Weeks STANDARD_DEVIATION 328.3 |
| Time Since MBC Diagnosis | 7.5 Weeks STANDARD_DEVIATION 34 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 92 / 317 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants According to Reasons for Treatment Discontinuation
The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.
Time frame: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Provider-documented disease progression | 133 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Death | 20 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Insurance/cost-related | 1 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Patient preference | 15 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Toxicity | 44 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | Other | 17 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Reasons for Treatment Discontinuation | No information | 20 Participants |
Primary
Overall Survival (OS)
Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time frame: From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Overall Survival (OS) | 44.1 Weeks |
Primary
Percentage of Participants With Provider Documented Disease Progression
Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.
Time frame: From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Fulvestrant | Percentage of Participants With Provider Documented Disease Progression | 42.0 Percentage of participants |
Primary
Real-World Duration of Treatment (rwDOT)
Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time frame: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Real-World Duration of Treatment (rwDOT) | 15.8 Weeks |
Primary
Real-World Progression-Free Survival (rwPFS)
The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.
Time frame: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Real-World Progression-Free Survival (rwPFS) | 19.6 Weeks |
Primary
Real-World Time to Tumor Progression (rwTTP)
The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.
Time frame: From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Real-World Time to Tumor Progression (rwTTP) | 26.7 Weeks |
Primary
Time to Chemotherapy
Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time frame: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Time to Chemotherapy | NA Weeks |
Primary
Time to Next Treatment (TTNT) From Index Treatment
Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time frame: From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Time to Next Treatment (TTNT) From Index Treatment | 16.8 Weeks |
Other Pre-specified
Duration of Treatment for Advanced Metastatic Breast Cancer
The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure.
Time frame: From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib + Fulvestrant | Duration of Treatment for Advanced Metastatic Breast Cancer | 44.7 Weeks |
Other Pre-specified
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure.
Time frame: Quarter(Q)1 2015,Q2 2015,Q3 2015,Q4 2015,Q1 2016,Q2 2016,Q3 2016,Q4 2016,Q1 2017,Q2 2017,Q3 2017,Q4 2017,Q1 2018,Q2 2018,Q3 2018,Q4 2018,Q1 2019,Q2 2019,Q3 2019,Q4 2019(data was retrieved and observed during 2.5 years of this retrospective 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 + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q4 2019 | 27 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Quarter (Q) 1 2015 | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q2 2015 | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q3 2015 | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q4 2015 | 0 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q1 2016 | 10 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q2 2016 | 12 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q3 2016 | 8 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q4 2016 | 18 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q1 2017 | 17 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q2 2017 | 24 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q3 2017 | 30 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q4 2017 | 31 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q1 2018 | 23 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q2 2018 | 21 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q3 2018 | 15 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q4 2018 | 18 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q1 2019 | 18 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q2 2019 | 25 Participants |
| Palbociclib + Fulvestrant | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Q3 2019 | 20 Participants |
Other Pre-specified
Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment
The percentage of participants classified according to the dosing strength of Palbociclib and Fulvestrant as their index treatment were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period.
Time frame: At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib + Fulvestrant | Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment | Fulvestrant at 500 Milligram (mg) | 93.4 Percentage of participants |
| Palbociclib + Fulvestrant | Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment | Palbociclib at 125 mg | 92.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Change in Dose
The percentage of participants with dose change for index treatment were reported in this outcome measure.
Time frame: From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib + Fulvestrant | Percentage of Participants With Change in Dose | Yes | 77.6 Percentage of participants |
| Palbociclib + Fulvestrant | Percentage of Participants With Change in Dose | No change/no documentation | 22.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer
Percentage of participants with prior adjuvant hormonal treatment for breast cancer were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period.
Time frame: Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib + Fulvestrant | Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer | 43.7 Percentage of participants |