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NCT04735367 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04735367
Other study ID # A5481154
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2021
Est. completion date September 29, 2023

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date September 29, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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 exclusion criteria for this study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• palbociclib plus letrozole
palbociclib plus letrozole

Locations
Country Name City State
Japan Chiba cancer center Chiba-shi Chiba
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Hospital Organization Kyushu Cancer Center Fukuoka
Japan Hiroshima City Hiroshima Citizens Hospital Hiroshima-city Hiroshima
Japan Hakuaikai Medical Corporation Sagara Hospital Kagoshima
Japan Saitama Cancer Center Kita-adachi-gun Saitama
Japan Kumamoto Shinto General Hospital Kumamoto
Japan Kumamoto University Hospital Kumamoto-city Kumamoto
Japan Kyoto University Hospital Kyoto
Japan National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Japan Aichi Cancer Center Nagoya
Japan National Hospital Organization - Osaka National Hospital - Institute For Clinical Research Osaka
Japan National Hospital Organization Hokkaido Cancer Center Sapporo Hokkaido

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Type of subsequent therapy after palbociclib plus letrozole Date of first treatment dose until death or end of study collection on 31 Dec 2024
Secondary Duration of subsequent therapy after palbociclib plus letrozole Date of first treatment dose until death or end of study collection on 31 Dec 2024
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