OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

NCT Number	NCT06016738
Lead Sponsor	Olema Pharmaceuticals, Inc.
Conditions	Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Enrollment	510 participants
Start Date	2023-11-16
Primary Completion	2026-10-31 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2026-08-13