Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
Start Date
7/3/2020
Completion Date
7/3/2035
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 blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.
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 that could provide a more precise approach to drug dosing. III. Interrogate biomarkers related to response and acquired resistance in standard clinical practice. IV. Develop patient-derived models from resistant disease to functionally assess the mechanisms occurring with resistance. V. Elucidate the socio-demographic features related to the use of ciclibs clinically in the Roswell Park catchment area. OUTLINE: Patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis/treatment decision, biomarker assessments, and description of mechanisms of resistance/response related to ciclib-therapy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cytology Specimen Collection Procedure
Diagnostic Laboratory Biomarker Analysis
Medical Chart Review
Conditions
Locations
Roswell Park Cancer Institute
Buffalo, New York 14263
United States