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OPERA-02: palazestrant + ribociclib versus letrozole + ribociclib in first-line ER-positive, HER2-negative advanced breast cancer

2025-522873-12-00Phase 3Authorised

Sponsor
Olema Oncology
Start
Feb 2026
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Small Molecules
Countries
27
01

Overview

Phase 3, randomised, double-blind trial in breast cancer comparing Palazestrant + ribociclib with Letrozole + ribociclib (2 arms). Primary endpoint: Local investigator-assessed progression-free survival. Planned start Feb 2026; status: authorised.

02

Drugs

palazestrantribociclibletrozole
03

Conditions

breast cancer

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