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Clinical trial

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

NCT07085767 is registered in ClinicalTrials.gov with Olema Pharmaceuticals, Inc. as lead sponsor.

NCT NCT07085767
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)
Lead sponsor
Olema Pharmaceuticals, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
November 3, 2025
Completion date
January 31, 2032
Enrollment
1,000 (estimated)
Sites
200

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer, er positive breast cancer, her2 negative breast carcinoma, locally advanced breast cancer, metastatic breast cancer