▪ 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.
Yeon Hee Park
Lead sponsor
Samsung Medical Center
Sponsor institution