Manning

Researchers are investigating the combination of ribociclib and standard adjuvant endocrine therapy ET to assess its effect on invasive breast cancer-free survival iBCFS in adults with hormone receptor-positive HR, HER2-negative early breast cancer at Anatomic Stage Groups III, IIB, and a subset of IIA. This phase IIIb, open-label, single-arm study involves patients close to typical clinical practice settings to better understand the treatments efficacy and safety. Participants receive ribociclib 400 mg orally once daily on days 1 to 21 of each 28-day cycle, alongside daily ET for 36 months, approximately 39 cycles. ET options vary by menopausal status and sex, including letrozole, anastrozole, or exemestane for postmenopausal women, and the same drugs combined with goserelin or leuprolide injections for preperimenopausal women and men. The treatment period starts with the first dose of ribociclib and ends 30 days after the last dose, followed by a safety follow-up call. During the study, participants undergo screening before treatment begins. After completing treatment, they enter a follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant starts treatment. Researchers monitor outcomes including iBCFS at 3 years, adverse events, various survival measures, dose intensity, treatment discontinuation timing, and quality of life assessments up to approximately 6 years. Safety follow-up is conducted 30 days post-treatment to ensure participant well-being.