Effectiveness of Adding Everolimus to the First-line Treatment of Advanced Breast Cancer in Premenopausal Women Who Experienced Disease Progression While Receiving Selective Estrogen Receptor Modulators: A Phase 2 Randomized Clinical Trial

This 2021 phase 2 randomized clinical trial (MIRACLE study) assessed the benefit of adding everolimus to letrozole in premenopausal women with hormone receptor-positive, ERBB2-negative advanced breast cancer who had progressed on selective estrogen receptor modulators (SERMs). A total of 199 patients were randomized to receive either everolimus (10 mg/day) with