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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 May 2026

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At a glance

  • Drugs Letrozole (Primary) ; Palazestrant (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OPERA-02
  • Sponsors Olema Pharmaceuticals

Most Recent Events

  • 21 Apr 2026 According to an Olema Pharmaceuticals media release, a trial-in-progress poster will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29-June 2 in Chicago, Illinois.
  • 16 Mar 2026 According to an Olema Pharmaceuticals media release, company presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.
  • 10 Nov 2025 According to an Olema Pharmaceuticals media release, the data from the trial will be presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.

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