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Pivotal Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer (OPERA-02).

Trial Profile

Pivotal Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer (OPERA-02).

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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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.

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