On March 2025, The Lancet Oncology published results from the UCBG 3-06 START phase 2 trial, comparing darolutamide and capecitabine in patients with triple-negative, androgen receptor-positive (AR+) advanced breast cancer.
Although the study didn’t meet its prespecified primary endpoint using immunohistochemistry-defined AR positivity, a notable clinical benefit (57%) was observed with darolutamide in patients classified as MAhigh by RNA profiling. These findings support the growing importance of transcriptomic-based selection for future trials involving anti-androgen therapy in TNBC.
This trial reflects a critical step in refining personalized approaches to TNBC and highlights the value of molecular profiling beyond IHC.

Many thanks to Prof. Hervé Bonnefoi and the UCBG team for this important contribution to breast cancer research.
For more details: https://lnkd.in/dwv3ZS5v