Primary Endpoint Analysis of a Randomized Phase II Trial of Darolutamide or Capecitabine in Patients With Triple-Negative Androgen Receptor-Positive Advanced Breast Cancer (UCBG3-06 START Trial)

A subgroup of triple negative breast cancer (TNBC) expresses the androgen receptor (AR). This trial evaluated the efficacy and tolerability of the AR inhibitor darolutamide or capecitabine in patients with advanced AR-positive TNBC. Despite not reaching the pre-specified clinical benefit rate, darulotamide demonstrated clinical activity with significant benefit for a group of patients. A research program to identify predictive biomarkers of sensitivity is ongoing.