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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04735367
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study Start: 2021-02-03
• Study First Posted: 2021-02-03
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

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Exclusion Criteria

1. There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of subsequent therapy after palbociclib plus letrozole	Date of first treatment dose until death or end of study collection on 31 Dec 2024
Type of subsequent therapy after palbociclib plus letrozole	Date of first treatment dose until death or end of study collection on 31 Dec 2024

Trial Locations

Locations (13)

Saitama Cancer Center; 🇯🇵 Kita-adachi-gun, Saitama, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama, Ehime, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research; 🇯🇵 Osaka, Japan

Chiba cancer center; 🇯🇵 Chiba-shi, Chiba, Japan

Aichi Cancer Center; 🇯🇵 Nagoya, Japan

National Hospital Organization Hokkaido Cancer Center; 🇯🇵 Sapporo, Hokkaido, Japan

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

Hakuaikai Medical Corporation Sagara Hospital; 🇯🇵 Kagoshima, Japan

Hiroshima City Hiroshima Citizens Hospital; 🇯🇵 Hiroshima-city, Hiroshima, Japan

Kumamoto University Hospital; 🇯🇵 Kumamoto-city, Kumamoto, Japan

Kumamoto Shinto General Hospital; 🇯🇵 Kumamoto, Japan