A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02).

Pi: Giulia Bianchi

The study is an open-label, multicenter, 1:1 randomized trial in patients with HR+, HER2-low breast cancer whose disease has progressed with at least 2 prior lines of endocrine therapy or within 6 months of first-line endocrine therapy + CDK4/6 inhibitor in the metastatic setting. The primary objective of the study is to determine the efficacy and safety of DB-1303 compared to investigator-selected single-agent chemotherapy in the target population. The protocol design therefore includes two arms represented by DB-1303 (ARM A) versus standard therapy (ARM B).