A Phase II Study of Ribociclib And Endocrine Treatment of Physician’s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

UVA Tracking #
HSR220277
Principal Investigator
Trish A Millard
Contact
Contact Phone
Official Trial Title
A Phase II Study of Ribociclib And Endocrine Treatment of Physician’s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have recurrent breast cancer. The main reason for you to take part in this study is to find out if researchers can lower the chance of your breast cancer coming back again by adding a drug called ribociclib to the usual hormone therapy drugs.

The usual approach for patients who are not in a study is to receive surgery and sometimes radiation followed by hormone therapy. Hormone therapy (also called endocrine therapy) are drugs that either lower estrogen levels or block estrogen receptors on breast cancer cells. Participants in this study will receive standard of care treatments as well as a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care. The drugs will be stopped if your disease comes back or the side effects become too severe.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05467891

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation