N/A
Completed N=42
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
Source: ClinicalTrials.gov NCT04735367 ↗Enrolled (actual)
42
Serious AEs
—
Results posted
Dec 2025
Primary outcomePrimary: Overall Survival (OS) — 85.42 Months
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
85.42 | — |
| SECONDARY Percentage of Participants According to Types and Line of Subsequent Treatment |
81.0; 69.0; 0.0; 7.1; 4.8; 69.0 | — |
| SECONDARY Duration of Subsequent Therapy by Line of Therapy |
7.64; 6.01 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04735367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.