Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Metastatic Breast Carcinoma
- Prognostic Stage IV Breast Cancer AJCC v8
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 res...
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.
Tracking Information
- NCT #
- NCT04526587
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Agnieszka K Witkiewicz Roswell Park Cancer Institute