NCT04526587

Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors

The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
OTHER	Medical Chart Review	Patient's electronic health records are reviewed

Timeline

• Start date: 2020-07-03
• Primary completion: 2030-07-03
• Completion: 2035-07-03
• First posted: 2020-08-26
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States