21
Participants
Start Date
May 20, 2021
Primary Completion Date
October 30, 2023
Study Completion Date
October 30, 2023
Ribociclib
Patients will receive ribociclib 600 mg oral (PO) daily for 21 consecutive days of 28-day cycles and endocrine therapy with either letrozole or fulvestrant. Fulvestrant 500 mg intramuscular (IM) will be administered on days 1, 15, 29 of cycle one, and then monthly. Letrozole 2.5 mg oral daily continuously. If premenopausal women have not undergone bilateral salpingo- oophorectomy, they will receive a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin leuprolide) for ovarian suppression in combination with fulvestrant or letrozole and ribociclib.
MedStar Georgetown University Hospital, Washington D.C.
Medstar Washington Hospital Center, Washington D.C.
Tufts Medical Center, Boston
Collaborators (2)
Medstar Health Research Institute
OTHER
Breast Cancer Research Foundation
OTHER
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS)
OTHER
National Cancer Institute (NCI)
NIH
Georgetown University
OTHER