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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04735367

Collaborator

(none)

Enrollment

Locations

22.9

Anticipated Duration (Months)

3.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: palbociclib plus letrozole

Study Design

Study Type:

Observational

Anticipated Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 3, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

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

Type of subsequent therapy after palbociclib plus letrozole [Date of first treatment dose until death or end of study collection on 31 Dec 2022]
Duration of subsequent therapy after palbociclib plus letrozole [Date of first treatment dose until death or end of study collection on 31 Dec 2022]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

There are no exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiba cancer center	Chiba-shi	Chiba	Japan	260-8717
2	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime	Japan	791-0280
3	Hiroshima City Hiroshima Citizens Hospital	Hiroshima-city	Hiroshima	Japan	730-8518
4	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido	Japan	003-0804
5	Kumamoto University Hospital	Kumamoto-city	Kumamoto	Japan	860-8556
6	Saitama Cancer Center	Kita-adachi-gun	Saitama	Japan	362-0806
7	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
8	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
9	Hakuaikai Medical Corporation Sagara Hospital	Kagoshima		Japan	892-0833
10	Kumamoto Shinto General Hospital	Kumamoto		Japan	862-8655
11	Kyoto University Hospital	Kyoto		Japan	606-8507
12	Aichi Cancer Center	Nagoya		Japan	464-8681
13	National Hospital Organization - Osaka National Hospital - Institute For Clinical Research	Osaka		Japan	540-0006