Status:
COMPLETED
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 1\. There are no exclusion criteria for this study.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04735367
Start Date
February 3 2021
End Date
September 29 2023
Last Update
December 9 2025
Active Locations (13)
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1
Chiba cancer center
Chiba, Chiba, Japan, 260-8717
2
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
3
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan, 730-8518
4
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804