CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. “Investigational” means that the drug is being studied.
This research study is a study with endocrine therapy and CDK 4/6 inhibitor (ribociclib) for early breast cancer. There is no placebo in this study. The study has two components – pre-screening with ctDNA to detect minimal residual disease (pre-screening), and treatment with ribociclib in combination with endocrine therapy (main portion).
The FDA (the U.S. Food and Drug Administration) has approved ribociclib in combination with aromatase inhibitors as a treatment option for advanced/metastatic (stage IV) breast cancer.
In this research study, the investigators are evaluating efficacy of ribociclib in patients who have MRD based on ctDNA.
Ribociclib is a drug designed to block certain proteins called cyclin-dependent protein kinases 4 and 6 (CDK4/6). These proteins are needed for cells to divide and may also control the ability of certain cancers to grow. The investigators believe that ribociclib may stop the participant cancer cells from growing and dividing by blocking these CDK4/6 proteins.

Source: View full study details on ClinicalTrials.gov

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January 10, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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