Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2031

Study Completion Date

December 31, 2031

Conditions
Breast Cancer Metastatic
Interventions
DRUG

Ribociclib with fulvestrant

"▪ Ribociclib group~\- Ribociclib (600 mg orally once daily on days 1 to 21 in a 28 day cycle) + Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day 15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)"

DRUG

Physician's choice treatments group

"▪Fulvestrant or exemestane group~1. Fulvestrant (500mg intramuscular injection on day 1 in a 28 day cycle and day15 of Cycle 1) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or periomenopausal women) OR,~2. Exemestane (25 mg orally once daily on day 1 to 28 in a 28 day cycle) + Everolimus (10 mg orally once daily on day 1 to 28 in a 28 day cycle) ± Leuprorelin (3.75 mg subcutaneously every 28 days in premenopausal or perimenopausal women)"

All Listed Sponsors
lead

Yeon Hee Park

OTHER