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

NCT04526587 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-11-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Agnieszka K Witkiewicz · Roswell Park Cancer Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2030-07-03
Completion
2035-07-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526587 on ClinicalTrials.gov