Breast Cancer
Conditions
Keywords
retrospective, multicenter, observational study, Japan, HR+/HER2- advanced breast cancer, palbociclib, overall survival
Brief summary
This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).
Interventions
DRUGpalbociclib plus letrozole
palbociclib plus letrozole
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2. 2. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. For patients who had already passed away, the conduct of this study will be disclosed, and the patients' legally acceptable representatives will be guaranteed an opportunity to refuse data collection for the patients in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects
Exclusion criteria
1\. There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study | OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants According to Types and Line of Subsequent Treatment | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study | Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy). |
| Duration of Subsequent Therapy by Line of Therapy | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study | Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used. |
Countries
Japan
Participant flow
Pre-assignment details
Data was collected from participants who were treated with palbociclib plus letrozole in Japanese Phase 2 study A5481010 (NCT01684215). Data was collected retrospectively from individual participant medical records for participants under survival follow up at the time of completion of study A5481010 and for participants who died or refused follow-up in study A5481010, data collected in Phase 2 study was used for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib+ Letrozole Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215). | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Palbociclib+ Letrozole | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 16 Participants | — |
| Age, Categorical Between 18 and 65 years | 26 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 42 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Survival (OS)
OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis.
Time frame: From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study
Population: Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib+ Letrozole | Overall Survival (OS) | 85.42 Months |
Secondary
Duration of Subsequent Therapy by Line of Therapy
Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used.
Time frame: From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study
Population: Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib+ Letrozole | Duration of Subsequent Therapy by Line of Therapy | First Subsequent Therapy | 7.64 Months |
| Palbociclib+ Letrozole | Duration of Subsequent Therapy by Line of Therapy | Second Subsequent Therapy | 6.01 Months |
Secondary
Percentage of Participants According to Types and Line of Subsequent Treatment
Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy).
Time frame: From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study
Population: Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Second Subsequent Therapy: Endocrine therapy + Chemotherapy | 2.4 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Second Subsequent Therapy: Chemotherapy | 21.4 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Received First Subsequent Therapy | 81.0 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | First Subsequent Therapy: Endocrine-based therapy | 69.0 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | First Subsequent Therapy: Endocrine therapy + Chemotherapy | 0.0 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | First Subsequent Therapy: Chemotherapy | 7.1 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | First Subsequent Therapy: Other | 4.8 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Received Second Subsequent Therapy | 69.0 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Second Subsequent Therapy: Endocrine-based therapy | 40.5 Percentage of participants |
| Palbociclib+ Letrozole | Percentage of Participants According to Types and Line of Subsequent Treatment | Second Subsequent Therapy: Other | 4.8 Percentage of participants |