OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Recruiting now · Phase 3
Conditions studied: Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06016738
- Run by
- Olema Pharmaceuticals, Inc.
- People needed
- 510
- Starts
- 2023-11-16
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Trial Site — Saint Louis Park, Minnesota, United States (enrolling)
- Clinical Trial Site — Lincoln, Nebraska, United States (enrolling)
- Clinical Trial Site — Tucson, Arizona, United States (enrolling)
- Clinical Trial Site — Detroit, Michigan, United States (enrolling)
- Clinical Trial Site — Los Angeles, California, United States (enrolling)
- Clinical Trial Site — Woodbury, Minnesota, United States (enrolling)
- Clinical Trial Site — Aurora, Colorado, United States (enrolling)
- Clinical Trial Site — Denver, Colorado, United States (enrolling)
- Clinical Trial Site — Golden, Colorado, United States (enrolling)
- Clinical Trial Site — Boston, Massachusetts, United States (enrolling)
- Clinical Trial Site — Danbury, Connecticut, United States (enrolling)
- Clinical Trial Site — Newark, Delaware, United States (enrolling)
- Clinical Trial Site — Whittier, California, United States (enrolling)
- Clinical Trial Site — Margate, Florida, United States (enrolling)
- Clinical Trial Site — Orlando, Florida, United States (enrolling)
- Clinical Trial Site — Plantation, Florida, United States (enrolling)
- Clinical Trial Site — Tamarac, Florida, United States (enrolling)
- Clinical Trial Site — Atlanta, Georgia, United States (enrolling)
- Clinical Trial Site — Chicago, Illinois, United States (enrolling)
- Clinical Trial Site — Chicago, Illinois, United States (enrolling)
- Clinical Trial Site — Urbana, Illinois, United States (enrolling)
- Clinical Trial Site — Los Alamitos, California, United States (enrolling)
- Clinical Trial Site — New Orleans, Louisiana, United States (enrolling)
- Clinical Trial Site — Baltimore, Maryland, United States (enrolling)
- Clinical Trial Site — Farmington, New Mexico, United States (enrolling)
Full record on ClinicalTrials.gov
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