Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts

PHASE4TerminatedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

May 20, 2021

Primary Completion Date

October 30, 2023

Study Completion Date

October 30, 2023

Conditions
Breast Cancer
Interventions
DRUG

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.

Trial Locations (3)

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

Medstar Washington Hospital Center, Washington D.C.

02111

Tufts Medical Center, Boston

All Listed Sponsors
collaborator

Medstar Health Research Institute

OTHER

collaborator

Breast Cancer Research Foundation

OTHER

collaborator

Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS)

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Georgetown University

OTHER