OPTIMA Trial Design - Prosigna-Guided Chemotherapy Decisions in High-Risk Breast Cancer

Dr. Zunairah Shah introduces OPTIMA as building on RxPONDER, which used Oncotype DX to guide chemotherapy decisions but left open whether benefit in premenopausal, low-score patients came from chemotherapy or ovarian suppression, and excluded patients with three to nine positive nodes. OPTIMA enrolled patients 40 and older with three to nine positive nodes, randomizing them to standard chemotherapy plus endocrine therapy or Prosigna-guided therapy, where a score of 60 or below allowed skipping chemotherapy for ovarian suppression plus endocrine therapy alone. Four-year overall survival was statistically similar between arms — 94% in both.