Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
NCT ID: NCT04735367
Last Updated: 2025-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
42 participants
OBSERVATIONAL
2021-02-03
2023-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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palbociclib plus letrozole
palbociclib plus letrozole
Eligibility Criteria
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Inclusion Criteria
2. 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
20 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Chiba cancer center
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, , Japan
Kumamoto Shinto General Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Aichi Cancer Center
Nagoya, , Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka, , Japan
Countries
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References
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Takahashi M, Yasojima H, Osako T, Inoue K, Kawashima M, Maeda H, Ito M, Sagara Y, Yonemori K, Hattori M, Yamamoto N, Muramatsu Y, Matsui A, Masuda N. Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis. Breast Cancer. 2025 Nov;32(6):1482-1490. doi: 10.1007/s12282-025-01760-0. Epub 2025 Aug 21.
Takahashi M, Osako T, Yasojima H, Inoue K, Kawashima M, Maeda H, Ichikawa A, Muramatsu Y, Masuda N. Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole. Breast Cancer. 2024 Jan;31(1):53-62. doi: 10.1007/s12282-023-01511-z. Epub 2023 Oct 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT04735367
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5481154
Identifier Type: -
Identifier Source: org_study_id
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