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Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Study acronym: OPERA-02
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 181 → 200 locations Eligibility criteria expanded, about 14 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 14 words
  2. Trial sites expanded: 167 → 181 locationsv11
  3. Trial sites expanded: 150 → 167 locationsv10
  4. Trial sites expanded: 124 → 150 locationsv9
  5. Trial sites expanded: 85 → 124 locationsv8
  6. Trial sites expanded: 35 → 85 locationsv7
  7. Study sites: 22 to 35v6
  8. Study sites: 17 to 22v5
  9. Study sites: 12 to 17v4
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 10 to 12 · Start date changed from estimate of Oct 31, 2025 to Nov 3, 2025v3 Show 2 more changesShow less
    • Study sites: 10 to 12
    • Start date changed from estimate of Oct 31, 2025 to Nov 3, 2025
  11. Study sites: 0 to 10v2
  12. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Trial Details
NCT Number NCT07085767
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Novartis Pharmaceuticals
Conditions Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov