Pivotal Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer (OPERA-02).
Latest Information Update: 30 May 2025
At a glance
- Drugs Palazestrant (Primary) ; Ribociclib (Primary)
- Indications Advanced breast cancer; HER2 negative breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms OPERA-02
Most Recent Events
- 28 May 2025 According to an Olema Pharmaceuticals media release, company announced FDA also selected 90 mg of palazestrant in combination with the approved dose of CDK4/6 inhibitor ribociclib for the pivotal Phase 3 OPERA-02 trial
- 02 Dec 2024 According to an Olema Pharmaceuticals media release, company announces a new clinical trial collaboration and supply agreement with Novartis, under the terms of the agreement, Novartis will provide Olema with ribociclib drug supply for the planned, Olema-sponsored, Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer.
- 02 Dec 2024 According to an Olema Pharmaceuticals media release, the company expects trial initiation expected in mid-2025.