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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04526587
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 3, 2020
Status verified
Nov 2025
Primary completion
Jul 3, 2030
Completion
Jul 3, 2035

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: Basic science (medical chart review, biospecimen collection)
    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.

Primary Outcome Measure

Collection of clinical characteristics [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Agnieszka K. Witkiewicz
[email protected]
716-845-1224
Agnieszka K. Witkiewicz (PRINCIPAL_INVESTIGATOR)

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Roswell Park Cancer Institute· Buffalo, NY

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