Study on Androgen Receptor and Triple Negative Breast Cancer

Summary

This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2. The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.

Timeline

Start

2018-03-14

Primary completion

2021-11-30

Completion

2022-07-20

Publications

• Bonnefoi H, Lerebours F, Pulido M, Arnedos M, Tredan O, Dalenc F, Guiu S, Teixeira L, Mollon D, Levy C, Verret B, Dawood H, Deiana L, Mouret Reynier MA, Augereau P, Canon JL, Huchet N, Guyonneau C, Lemonnier J, MacGrogan G, Goncalves A, Darbo E, Iggo R. Darolutamide or capecitabine in triple-negative, androgen receptor-positive, advanced breast cancer (UCBG 3-06 START): a multicentre, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):355-366. doi: 10.1016/S1470-2045(24)00737-X. Epub 2025 Feb 17.

Drugs

Indications