Trial Outcomes & Findings for RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S. (NCT NCT04460898)
NCT ID: NCT04460898
Last Updated: 2024-10-04
Results Overview
Number of participants according to their year of initial diagnosis of breast cancer were reported.
COMPLETED
195 participants
Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
2024-10-04
Participant Flow
Data of metastatic breast cancer participants who received palbociclib and letrozole (LET) as initial endocrine therapy on or after 03 February 2015 up to Feb 11, 2019 (approximately 4 years) at community oncology practices in the U.S. as per FDA approval labels, were observed retrospectively. Data from medical records of eligible participants were collected by their treating physician. Data were identified and evaluated for 5.7 months approximately in this observational study.
Participant milestones
| Measure |
Palbociclib + LET
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Overall Study
STARTED
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195
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|
Overall Study
COMPLETED
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195
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Baseline characteristics by cohort
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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Age, Continuous
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64.92 Years
STANDARD_DEVIATION 10.47 • n=5 Participants
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Sex: Female, Male
Female
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195 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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25 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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170 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
Number of participants according to their year of initial diagnosis of breast cancer were reported.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Prior to 2011
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27 Participants
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Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Jan 2019
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1 Participants
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Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Jan 2011 to Dec 2014
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28 Participants
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Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Jan 2015 to Dec 2018
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139 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
AJCC stages included: stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), and unknown. T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 =2-5 cm, T3 = greater than (\>) 2 cm, T4 = large sized, N0 = not spread to lymph node (LN), N1 = spread to LN 1 to 3, N2= spread to LN 4 to 9, N3 = spread \>10 axillary LN, M0 = no metastasis, M1= metastasis.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IV
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128 Participants
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Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Unknown
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1 Participants
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Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage I
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15 Participants
|
|
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IIA
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16 Participants
|
|
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IIB
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17 Participants
|
|
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IIIA
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11 Participants
|
|
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IIIB
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4 Participants
|
|
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Stage IIIC
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3 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with node status ranging from N0 to Nx were recorded and reported. N0= No regional lymph node involvement (no cancer found in the lymph nodes), N1-N3= involvement of regional lymph nodes (number and/or extent of spread), and Nx = regional lymph nodes cannot be evaluated. N2 included N2A, and N2B stages; N3 included N3A, N3B, and N3C stages.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Node Status
N0
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44 Participants
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Number of Participants With Node Status
N2A
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14 Participants
|
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Number of Participants With Node Status
N2B
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10 Participants
|
|
Number of Participants With Node Status
N3A
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6 Participants
|
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Number of Participants With Node Status
N3B
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4 Participants
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Number of Participants With Node Status
N3C
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7 Participants
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Number of Participants With Node Status
Nx
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66 Participants
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Number of Participants With Node Status
N1
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44 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with menopausal status were recorded and reported. Menopausal status included pre-menopausal, peri-menopausal and post-menopausal.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Menopausal Status
Pre-menopausal
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7 Participants
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Number of Participants With Menopausal Status
Peri-menopausal
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5 Participants
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Number of Participants With Menopausal Status
Post-menopausal
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183 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with de novo metastatic and recurrent types of metastatic disease were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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Number of Participants With Type of Metastatic Disease
De novo metastatic
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128 Participants
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Number of Participants With Type of Metastatic Disease
Recurrent metastatic
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67 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
Sites of metastatic disease included: locoregional site, adrenal gland, bone, brain, distant lymph nodes, gastrointestinal system, liver, lung, pleura, pericardial, and/or peritoneal cavity. A participant could have more than 1 metastatic site.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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Number of Participants With Sites of Metastatic Disease
Adrenal gland
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12 Participants
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Number of Participants With Sites of Metastatic Disease
Bone
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141 Participants
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Number of Participants With Sites of Metastatic Disease
Brain
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2 Participants
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Number of Participants With Sites of Metastatic Disease
Distant lymph nodes
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47 Participants
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|
Number of Participants With Sites of Metastatic Disease
Gastrointestinal system
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1 Participants
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Number of Participants With Sites of Metastatic Disease
Liver
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24 Participants
|
|
Number of Participants With Sites of Metastatic Disease
Locoregional site
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8 Participants
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Number of Participants With Sites of Metastatic Disease
Lung
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69 Participants
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Number of Participants With Sites of Metastatic Disease
Pleura, pericardial, and/or peritoneal cavity
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8 Participants
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with total number of metastatic sites ranging from 1 to \>3 were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Total Number of Metastatic Sites
1
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82 Participants
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Number of Participants With Total Number of Metastatic Sites
2
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78 Participants
|
|
Number of Participants With Total Number of Metastatic Sites
>3
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35 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with ECOG at the time of initiation of first-line treatment were included. ECOG scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about \>50 percent (%) of waking hours; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
ECOG Status: 0
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68 Participants
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Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
ECOG Status: 1
|
107 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
ECOG Status: 3
|
3 Participants
|
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Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
ECOG Status: 4
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
ECOG Status: 2
|
17 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants with various comorbidities at the time of initiation of first-line treatment were recorded and reported. Comorbidities included acquired immune deficiency syndrome/human immune virus (AIDS/HIV), cardiovascular disease, cerebrovascular disease, chronic pulmonary disease, congestive heart failure, connective tissue disease, dementia, depression, diabetes with chronic complications, diabetes without chronic complications, hemiplegia or paraplegia, hypertension, liver disease - mild, moderate, or severe, myocardial infarction, other hematologic malignancy, other non-hematologic malignancy, peptic ulcer disease, peripheral vascular disease, renal disease, thromboembolic events (arterial or venous), and other. One participant could have more than 1 comorbidity. Data with "0" values has not been reported in this outcome measure.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Cerebrovascular disease
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6 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Chronic pulmonary disease
|
9 Participants
|
|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Congestive heart failure
|
7 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Connective tissue disease
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4 Participants
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Dementia
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3 Participants
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Depression
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22 Participants
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|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Diabetes without chronic complications
|
26 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Hypertension
|
109 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Liver disease - mild
|
3 Participants
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Myocardial infarction
|
2 Participants
|
|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Peptic ulcer disease
|
8 Participants
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Other
|
10 Participants
|
|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Cardiovascular disease
|
25 Participants
|
|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Diabetes with chronic complications
|
4 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Peripheral vascular disease
|
1 Participants
|
|
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Renal disease
|
5 Participants
|
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Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Thromboembolic events (arterial or venous)
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
CCI based on various comorbid conditions including myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, hemiplegia or paraplegia, renal disease, AIDS/HIV, diabetes with and without chronic complications, liver disease (mild, moderate, or severe) was reported. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Charlson Comorbidity Index (CCI) Score
|
0.52 Units on a scale
Standard Deviation 0.93
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
In this outcome measure, number of participants who received neo/adjuvant chemotherapy and hormonal (endocrine) therapy were recorded and reported. Neo/Adjuvant chemotherapy and hormonal therapy were the treatments administered before primary cancer treatment to enhance the outcome of primary treatment. Participants reported in rows below are not mutually exclusive.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
Adjuvant chemotherapy
|
31 Participants
|
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Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
Adjuvant endocrine therapy
|
51 Participants
|
|
Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
Both adjuvant chemotherapy/adjuvant endocrine therapy
|
25 Participants
|
PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + LET
n=57 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Duration of Adjuvant Therapy
|
41.7 Months
Standard Deviation 28.16
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PRIMARY outcome
Timeframe: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, time from discontinuation (in months) of adjuvant therapy up to the initiation of first-line treatment of palbociclib combination was recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=57 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Time From Discontinuation of Adjuvant Therapy to Initiation of First-line Treatment
|
39.32 Months
Standard Deviation 50.81
|
PRIMARY outcome
Timeframe: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, number of participants with different initial dose treatment patterns (125 milligram \[mg\]/day, 100 mg/day, and 75 mg/day) at palbociclib initiation were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=193 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Number of Participants With Different Initial Palbociclib Dose
125 mg/day
|
166 Participants
|
|
Number of Participants With Different Initial Palbociclib Dose
100 mg/day
|
26 Participants
|
|
Number of Participants With Different Initial Palbociclib Dose
75 mg/day
|
1 Participants
|
PRIMARY outcome
Timeframe: From first-line treatment up to the discontinuation of initial treatment of metastatic breast cancer during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Total number of cycles of treatment was the mean number of cycles received by participants prior to the discontinuation of initial treatment of metastatic breast cancer.
Outcome measures
| Measure |
Palbociclib + LET
n=193 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
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|---|---|
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Total Number of Treatment Cycles Received
|
13.73 Cycles
Standard Deviation 10.10
|
PRIMARY outcome
Timeframe: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, number of participants whose dose was reduced from 125 mg/day to 100 mg/day or from 125 mg/day to 75 mg/day, or from 100 mg/day to 75 mg/day were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=193 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Number of Participants With Dose Reductions
|
33 Participants
|
PRIMARY outcome
Timeframe: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, number of participants with increased dose patterns from 100 mg/day to 125 mg/day, 75 mg/day to 125 mg/day, and from 75 mg/day to 100 mg/day were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=193 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Number of Participants With Increased Dose Patterns
|
0 Participants
|
PRIMARY outcome
Timeframe: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, number of participants whose treatment was interrupted due to any reason (toxicity, no response, loss of response, disease progression (PD), prepare for alternative treatment strategy, participant choice or other) were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=193 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Number of Participants With Any Treatment Interruptions
|
17 Participants
|
PRIMARY outcome
Timeframe: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, mean of number of complete blood count (CBC) testing was recorded during first cycle of first line (1L) treatment. 1 cycle was of 28 days.
Outcome measures
| Measure |
Palbociclib + LET
n=192 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Frequency of CBC Testing During First Cycle of Treatment
|
2.07 CBC testing
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, mean of number of electrolyte testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Outcome measures
| Measure |
Palbociclib + LET
n=190 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Frequency of Electrolyte Testing During First Cycle of First Line Treatment
|
1.44 Electrolyte testing
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, mean of liver function testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Outcome measures
| Measure |
Palbociclib + LET
n=191 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Frequency of Liver Function Testing During First Cycle of First Line Treatment
|
1.37 Liver function testing
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Month 6 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Month 6
|
92.7 Percentage of participants
Interval 87.5 to 95.8
|
PRIMARY outcome
Timeframe: Month 12 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Month 12
|
75.5 Percentage of participants
Interval 67.5 to 81.9
|
PRIMARY outcome
Timeframe: Month 18 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Month 18
|
51.6 Percentage of participants
Interval 42.4 to 60.0
|
PRIMARY outcome
Timeframe: Month 24 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Month 24
|
42.0 Percentage of participants
Interval 32.7 to 51.0
|
PRIMARY outcome
Timeframe: From initiation of treatment up to death during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
OS was defined as the interval from the initiation of first line palbociclib combination treatment until death. Participants who were alive at the time of data collection were censored on the last date of visit with their provider.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 41.9 to
Median and upper limit for 95% CI could not be estimated because there were insufficient number of participants with event.
|
PRIMARY outcome
Timeframe: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (\>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Percentage of Participants With Clinical Benefit Rate (CBR)
|
83.08 Percentage of participants
|
PRIMARY outcome
Timeframe: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study.
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Outcome measures
| Measure |
Palbociclib + LET
n=195 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Objective Response Rate (ORR)
|
65.13 Percentage of participants
|
PRIMARY outcome
Timeframe: From initiation of treatment up to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Outcome measures
| Measure |
Palbociclib + LET
n=162 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Number of Participants With Stable Disease Lasting Greater Than (>) 24 Weeks
|
35 Participants
|
PRIMARY outcome
Timeframe: Post discontinuation of initial endocrine-based therapy during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
In this outcome measure, number of participants who received drug regimen after discontinuation of initial endocrine-based therapy were recorded and reported.
Outcome measures
| Measure |
Palbociclib + LET
n=76 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
Chemotherapy
|
44 Participants
|
|
Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
Endocrine therapy
|
28 Participants
|
|
Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
Other therapy
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months after palbociclib treatment initiation during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)Population: FAS included all participants who after clinical and analytical quality control assessment were retained for analysis in the study. Here 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Discontinuation referred to a treatment persistence terminal event other than regimen change or switch, disease progression, or death. Participants who had a termination of palbociclib for reasons other than regimen change or switch, disease progression, or death were recorded and reported as discontinued.
Outcome measures
| Measure |
Palbociclib + LET
n=18 Participants
Participants received palbociclib along with LET as initial endocrine-based therapy for advanced and metastatic breast cancer per FDA approval labels as part of their routine treatment. Data were retrieved and observed retrospectively for a period of 5.7 months approximately in this study.
|
|---|---|
|
Duration of Discontinued Therapy
|
8.48 Months
Standard Deviation 2.54
|
Adverse Events
Palbociclib + LET
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 publications 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