RecruitingNCT04526587

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


Sponsor

Roswell Park Cancer Institute

Enrollment

700 participants

Start Date

Jul 3, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting blood and tissue samples from patients with hormone receptor-positive (ER+), HER2-negative metastatic breast cancer who are being treated with CDK4/6 inhibitors (such as palbociclib, ribociclib, or abemaciclib) to find biomarkers that predict who responds best to these drugs. **You may be eligible if...** - You are an adult with ER+/HER2- metastatic breast cancer or high-risk early breast cancer - You are currently being treated with, or have been treated with, a CDK4/6 inhibitor (a class of targeted therapy drugs) - You are receiving this as standard of care or as part of another eligible study **You may NOT be eligible if...** - You have a different subtype of breast cancer (e.g., HER2-positive or triple-negative) - You have not received or are not eligible for CDK4/6 inhibitor therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCytology Specimen Collection Procedure

Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples

OTHERDiagnostic Laboratory Biomarker Analysis

Correlative studies

OTHERMedical Chart Review

Patient's electronic health records are reviewed


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT04526587


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