Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial.
Carlo Palmieri, Hannah Linden, Stephen N Birrell, Sally Wheelwright, Elgene Lim, Lee S Schwartzberg, Amy R Dwyer, Theresa E Hickey, Hope S Rugo, Patrick Cobb, Joyce A O'Shaughnessy, Stephen Johnston, Adam Brufsky, Wayne D Tilley, Beth Overmoyer
BACKGROUND: The androgen receptor is a tumour suppressor in oestrogen receptor-positive breast cancer. The activity and safety of enobosarm, an oral selective androgen receptor modulator, was evaluated in women with oestrogen receptor (ER)-positive, HER2-negative, and androgen receptor (AR)-positive disease. METHODS: Women who were postmenopausal (aged ≥18 years) with previously treated ER-positive, HER2-negative, locally advanced or metastatic breast cancer with an Eastern Cooperative Oncology Group performance status of 0-2 were enrolled in a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial done at 35 cancer treatment centres in nine countries...
February 8, 2024: Lancet Oncology