Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
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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).
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Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Accepts Healthy Volunteers:
Patients who participated, treated with palbociclib plus letrozole, and under follow-up for survival in J-Ph2
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
1. There are no exclusion criteria for this study.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Pfizer:
HR+/HER2- advanced breast cancer
Additional relevant MeSH terms:
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Neoplasms by Site
Steroid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors