Overview

• In the randomized Phase II CLEVER trial of 51 breast cancer survivors with minimal residual disease, short-course therapy cleared dormant cells in 80% of participants.
• Three-year recurrence-free survival exceeded 90% for patients on single-drug arms and reached 100% for those who received the two-drug combination.
• After a median 42 months of follow-up, only two patients in the cohort experienced a recurrence.
• Dormant cells were identified through bone marrow screening, and the study used FDA-approved drugs repurposed from other indications based on preclinical evidence involving autophagy and mTOR pathways.
• Researchers are enrolling larger Phase II studies, ABBY and PALAVY, to confirm efficacy and safety, with support from the National Cancer Institute, the Department of Defense, and major foundations.