Status:
RECRUITING
Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This study investigates the clinical course of CDK4/6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4/6 inhibitors may stop the growth of tumor cells by bl...
Detailed Description
PRIMARY OBJECTIVES: I. Delineate clinical features of disease progression and responses to subsequent therapy following progression on ciclib-based therapy. II. Define pharmacogenomics relationships...
Eligibility Criteria
Inclusion
- All adult patients with ER+/HER2- metastatic breast cancer or HR+/HER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study
- This includes patients receiving standard of care therapy for ER+/HER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital
- Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy
- Participant must understand the prospective nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form
Exclusion
- Pregnant of nursing female subjects
- Unwilling or unable to follow protocol requirements
Key Trial Info
Start Date :
July 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 3 2035
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04526587
Start Date
July 3 2020
End Date
July 3 2035
Last Update
November 13 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263