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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
Updated on 26 December 2021
advanced breast cancer


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 Breast Cancer
Treatment palbociclib plus letrozole
Clinical Study IdentifierNCT04735367
Last Modified on26 December 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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