Trial Outcomes & Findings for Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting. (NCT NCT04460911)
NCT ID: NCT04460911
Last Updated: 2024-01-11
Results Overview
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.
COMPLETED
317 participants
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)
2024-01-11
Participant Flow
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.
Data was retrieved from electronic healthcare record (EHR) and available data was evaluated over 2.5 years of this retrospective observational study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
317
|
|
Overall Study
COMPLETED
|
317
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Baseline characteristics by cohort
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Age, Continuous
|
67.3 Years
n=317 Participants
|
|
Age, Customized
18-50
|
22 Participants
n=317 Participants
|
|
Age, Customized
51-70
|
174 Participants
n=317 Participants
|
|
Age, Customized
More than (>) 70
|
121 Participants
n=317 Participants
|
|
Sex: Female, Male
Female
|
312 Participants
n=317 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=317 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 Participants
n=317 Participants
|
|
Race/Ethnicity, Customized
Not documented
|
41 Participants
n=317 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=317 Participants
|
|
Race/Ethnicity, Customized
White
|
239 Participants
n=317 Participants
|
|
Body Mass Index (BMI) at Index Date
|
28.8 Kilogram per square meter
STANDARD_DEVIATION 6.9 • n=317 Participants
|
|
Number of Participants According to Smoking history
Never smoked
|
111 Participants
n=317 Participants
|
|
Number of Participants According to Smoking history
Current smoker
|
18 Participants
n=317 Participants
|
|
Number of Participants According to Smoking history
Former smoker
|
81 Participants
n=317 Participants
|
|
Number of Participants According to Smoking history
No information
|
107 Participants
n=317 Participants
|
|
Number of Participants According to Family History of Cancer
Yes
|
206 Participants
n=317 Participants
|
|
Number of Participants According to Family History of Cancer
No/no information
|
111 Participants
n=317 Participants
|
|
Number of Participants According to Menopausal Status
Pre-menopausal
|
9 Participants
n=317 Participants
|
|
Number of Participants According to Menopausal Status
Peri-menopausal
|
1 Participants
n=317 Participants
|
|
Number of Participants According to Menopausal Status
Post-menopausal
|
287 Participants
n=317 Participants
|
|
Number of Participants According to Menopausal Status
No information
|
20 Participants
n=317 Participants
|
|
Time Since Initial BC Diagnosis
|
380.6 Weeks
STANDARD_DEVIATION 328.3 • n=316 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Time Since MBC Diagnosis
|
7.5 Weeks
STANDARD_DEVIATION 34.0 • n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Bone (single)
|
47 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Bone (multiple)
|
181 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Brain
|
8 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Liver (single)
|
19 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Liver (multiple)
|
43 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Lung (single)
|
28 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Lung (multiple)
|
41 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Lung (pleural effusion)
|
36 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Lymph nodes (regional)
|
32 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Lymph nodes (distant)
|
43 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Ovary
|
1 Participants
n=317 Participants
|
|
Number of Participants According to Distant Metastatic Sites
Other
|
47 Participants
n=317 Participants
|
|
Number of Participants According to Disease-Free Interval
Less than (<) 12 months
|
178 Participants
n=269 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Disease-Free Interval
More than or equal to (>=) 12 months
|
91 Participants
n=269 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Visceral/non-Visceral Status
Asymptomatic visceral disease
|
105 Participants
n=317 Participants
|
|
Number of Participants According to Visceral/non-Visceral Status
Bone only
|
117 Participants
n=317 Participants
|
|
Number of Participants According to Visceral/non-Visceral Status
Non-visceral disease
|
27 Participants
n=317 Participants
|
|
Number of Participants According to Visceral/non-Visceral Status
Not documented
|
14 Participants
n=317 Participants
|
|
Number of Participants According to Visceral/non-Visceral Status
Other
|
5 Participants
n=317 Participants
|
|
Number of Participants According to Visceral/non-Visceral Status
Symptomatic visceral disease
|
49 Participants
n=317 Participants
|
|
Number of Participants According to Count of Metastatic Sites
1
|
178 Participants
n=317 Participants
|
|
Number of Participants According to Count of Metastatic Sites
2
|
83 Participants
n=317 Participants
|
|
Number of Participants According to Count of Metastatic Sites
3
|
44 Participants
n=317 Participants
|
|
Number of Participants According to Count of Metastatic Sites
4+
|
12 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage I
|
0 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IA
|
18 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IB
|
3 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IIA
|
33 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IIB
|
31 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IIIA
|
26 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IIIB
|
4 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IIIC
|
12 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
Stage IV
|
41 Participants
n=317 Participants
|
|
Number of Participants According to Stage at Diagnosis
No information
|
149 Participants
n=317 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
73 Participants
n=317 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
107 Participants
n=317 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
26 Participants
n=317 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
More than or equal to (>=) 3
|
5 Participants
n=317 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Not documented
|
106 Participants
n=317 Participants
|
|
Number of Participants According to Comorbidities
Atrial fibrillation
|
6 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Cerebrovascular disease
|
3 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Congestive heart failure
|
4 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Chronic pulmonary disease
|
15 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Connective tissue disease
|
3 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Dementia
|
2 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Diabetes with end organ damage
|
10 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Diabetes without end organ damage
|
38 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Depression
|
29 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
|
1 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Hypertension
|
112 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Infection
|
1 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Long QT syndrome (drug induced)
|
1 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Mild liver disease
|
2 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Moderate to severe renal disease
|
9 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Myocardial infarction
|
3 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Peptic ulcer disease
|
2 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Peripheral vascular disease
|
1 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Tachycardia
|
1 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Stroke
|
3 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Venous thromboembolism (pulmonary embolism or deep vein thrombosis)
|
13 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Comorbidities
Hypotension
|
47 Participants
n=306 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Number of Participants According to Disease Histology
Ductal
|
142 Participants
n=317 Participants
|
|
Number of Participants According to Disease Histology
Lobular
|
27 Participants
n=317 Participants
|
|
Number of Participants According to Disease Histology
Other
|
3 Participants
n=317 Participants
|
|
Number of Participants According to Disease Histology
No information
|
145 Participants
n=317 Participants
|
|
Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status
Positive
|
4 Participants
n=317 Participants
|
|
Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status
Negative
|
27 Participants
n=317 Participants
|
|
Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status
Not documented
|
286 Participants
n=317 Participants
|
|
Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status
Positive
|
1 Participants
n=317 Participants
|
|
Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status
Negative
|
7 Participants
n=317 Participants
|
|
Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status
Not documented
|
309 Participants
n=317 Participants
|
|
Number of Participants According to Next Generation Sequencing (NGS) Status
Positive
|
7 Participants
n=317 Participants
|
|
Number of Participants According to Next Generation Sequencing (NGS) Status
Negative
|
5 Participants
n=317 Participants
|
|
Number of Participants According to Next Generation Sequencing (NGS) Status
No information
|
305 Participants
n=317 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Time to Chemotherapy
|
NA Weeks
Interval 33.5 to
Median and upper limit of 95% CI was not estimable due to Iess number of participants with an event.
|
PRIMARY outcome
Timeframe: 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.
The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=250 Participants
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.
|
|---|---|
|
Number of Participants According to Reasons for Treatment Discontinuation
Provider-documented disease progression
|
133 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Death
|
20 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Insurance/cost-related
|
1 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Patient preference
|
15 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Toxicity
|
44 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Other
|
17 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
No information
|
20 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Real-World Duration of Treatment (rwDOT)
|
15.8 Weeks
Interval 13.7 to 18.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Time to Next Treatment (TTNT) From Index Treatment
|
16.8 Weeks
Interval 14.7 to 22.0
|
PRIMARY outcome
Timeframe: 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.
Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Percentage of Participants With Provider Documented Disease Progression
|
42.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Real-World Time to Tumor Progression (rwTTP)
|
26.7 Weeks
Interval 21.6 to 34.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Real-World Progression-Free Survival (rwPFS)
|
19.6 Weeks
Interval 15.2 to 23.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Overall Survival (OS)
|
44.1 Weeks
Interval 39.4 to
Upper limit of 95% CI was not estimable due to Iess number of participants with an event.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 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.
The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Duration of Treatment for Advanced Metastatic Breast Cancer
|
44.7 Weeks
Interval 0.0 to 227.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=254 Participants
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.
|
|---|---|
|
Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer
|
43.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Quarter (Q) 1 2015
|
0 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q2 2015
|
0 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q3 2015
|
0 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q4 2015
|
0 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q1 2016
|
10 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q2 2016
|
12 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q3 2016
|
8 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q4 2016
|
18 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q1 2017
|
17 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q2 2017
|
24 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q3 2017
|
30 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q4 2017
|
31 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q1 2018
|
23 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q2 2018
|
21 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q3 2018
|
15 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q4 2018
|
18 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q1 2019
|
18 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q2 2019
|
25 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q3 2019
|
20 Participants
|
|
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
Q4 2019
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
The percentage of participants with dose change for index treatment were reported in this outcome measure.
Outcome measures
| Measure |
Palbociclib + Fulvestrant
n=317 Participants
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.
|
|---|---|
|
Percentage of Participants With Change in Dose
Yes
|
77.6 Percentage of participants
|
|
Percentage of Participants With Change in Dose
No change/no documentation
|
22.4 Percentage of participants
|
Adverse Events
Palbociclib + Fulvestrant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER