▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment
Participants must be at least 19 years of age at the time of signing the informed consent.
Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
Patient has HR-positive/HER2-negative invasive breast cancer (based on most recently analyzed biopsy)
HER2 status is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing, according to ASCO/CAP guidelines for HER2 testing (Wolff et al. 2018).
Patients whose cancer recurs one year or later after completing adjuvant endocrine therapy
Patients who have been free from endocrine therapy for at least 2 years
Patient whose disease recurred during or within 1 year from adjuvant CDK4/6 inhibitor treatment.
Patient who did receive adjuvant palbociclib irrespective of disease-free interval.
Parallel
Ribociclib with fulvestrant
Drug▪ 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)
Physician's choice treatments group
Drug▪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)
Progression Free Survival
From the time from randomization to first documented progression or death, whichever occurs first
Overall survival
From date of randomization to date of death due to any cause.
Objective Response Rate
Assessed by RECIST 1.1. Cinical benefit rate defined as percentage of patients with CR, PR per RECIST 1.1 or SD lasting 24 weeks or longer
Adverse Events
Incidence/severity of adverse events, lab abnormalities based on CTCAE4.03
Click on the lead sponsor to view all of their trials.
Yeon Hee Park
Lead sponsor
Samsung Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
