Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

Study Overview
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Brief Summary
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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).

Official Title
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Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: palbociclib plus letrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2. 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 exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: palbociclib plus letrozole|palbociclib plus letrozole|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival was the duration from the start of study treatment to death. | Date of first treatment dose until death or end of study collection on 31 Dec 2022, whichever is later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of subsequent therapy after palbociclib plus letrozole |  | Date of first treatment dose until death or end of study collection on 31 Dec 2024 | 
| Duration of subsequent therapy after palbociclib plus letrozole |  | Date of first treatment dose until death or end of study collection on 31 Dec 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retrospective, multicenter, observational study, Japan, HR+/HER2- advanced breast cancer, palbociclib, overall survival