Alyse W. Staley

Oct 5, 2024 | nature.com | Anthony Elias |Alyse W. Staley |Monica N. Fornier |Elena Shagisultanova |Rosa I. Gallagher |Jill E. Slansky | +1 more

AbstractMost ER+ breast cancers (BC) express androgen receptors (AR). This randomized phase II trial of 4 months of neoadjuvant fulvestrant (Fulv) alone or with enzalutamide (Combo) assessed whether adding AR blockade to Fulv would limit residual tumor at the time of surgery, as measured by modified preoperative endocrine predictive index (PEPI) score. Eligible patients were women with ER+/HER2− primary BC cT2 or greater. Stratification factors were clinical node and T-stage.

May 20, 2023 | nature.com | Anthony Elias |Elena Shagisultanova |Rosa I. Gallagher |Alyse W. Staley

Study design and treatmentsNCT02953860 (COMIRB 16–1001) was an open-label, non-randomized trial combining fulvestrant plus enzalutamide. All patients received fulvestrant 500 mg IM on days 1, 15, 29, and then every 4 weeks plus enzalutamide 160 mg po daily until disease progression or unacceptable toxicity. Pre- or peri-menopausal women received concurrent ovarian suppression with a gonadotropin-releasing hormone agonist.