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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Study acronym: OPERA-01
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2026 → Oct 31, 2026
See other at-risk trials from Olema Pharmaceuticals, Inc.

Record History

  1. Enrollment closed, study ongoing Primary completion pushed from Jun 30, 2026 to Oct 31, 2026 · Completion pushed from Sep 30, 2027 to Feb 29, 2028 · Site details revised at 233 of 233 sitesv31 Show 3 more changesShow less
    • Primary completion pushed from Jun 30, 2026 to Oct 31, 2026
    • Completion pushed from Sep 30, 2027 to Feb 29, 2028
    • Site details revised at 233 of 233 sites
  2. Study sites: 193 to 233v30
  3. Study sites: 174 to 193v29
  4. Trial status: Active, Not Recruiting to Recruiting Site details revised at 174 of 174 sitesv28 Show 1 more changeShow less
    • Site details revised at 174 of 174 sites
  5. Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 174 of 174 sitesv26 Show 1 more changeShow less
    • Site details revised at 174 of 174 sites
  2. Study sites: 171 to 174v25
  3. Re-verified, no change to tracked fieldsv24
  4. Study sites: 150 to 171v23
  5. Study sites: 120 to 150v22
  6. Study sites: 94 to 120v21
  7. Study sites: 78 to 94v20
  8. Study sites: 62 to 78v19
  9. Study sites: 54 to 62v18
  10. Study sites: 44 to 54v17
  11. Study sites: 42 to 44 Interventions: Anastrozole (Drug), Exemestane (Drug), Fulvestrant (Drug), Letrozole (Drug), OP-1250 (Drug) to Anastrozole (Drug), Exemestane (Drug), Fulvestrant (Drug), Letrozole (Drug), Palazestrant (Drug) · Eligibility criteria revised · Study description shortened, about 2 wordsv16 Show 3 more changesShow less
    • Interventions: Anastrozole (Drug), Exemestane (Drug), Fulvestrant (Drug), Letrozole (Drug), OP-1250 (Drug) to Anastrozole (Drug), Exemestane (Drug), Fulvestrant (Drug), Letrozole (Drug), Palazestrant (Drug)
    • Eligibility criteria revised
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 39 to 42v15
  13. Study sites: 34 to 39v14
  14. Study sites: 33 to 34v13
  15. Study sites: 27 to 33v12
  16. Study sites: 24 to 27v11
  17. Primary endpoints: 1 to 4 Study sites: 21 to 24 · Eligibility criteria expanded, about 7 words · Secondary endpoint revised · 1 morev10 Show 4 more changesShow less
    • Study sites: 21 to 24
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoint revised
    • Study description expanded, about 54 words

    See this version in full on ClinicalTrials.gov ↗

  18. Start date: Oct 10, 2023 to Nov 16, 2023 Study sites: 18 to 21v9 Show 1 more changeShow less
    • Study sites: 18 to 21
  19. Study sites: 11 to 18v8
  20. Re-verified, no change to tracked fieldsv7
  21. Study sites: 8 to 11v6
  22. Study sites: 7 to 8v5
  23. Study sites: 5 to 7v4
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of Oct 15, 2023 to Oct 10, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Oct 15, 2023 to Oct 10, 2023
  25. Eligibility criteria revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. 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 safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Trial Details
NCT Number NCT06016738
Lead Sponsor Olema Pharmaceuticals, Inc.
Conditions Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Enrollment 510 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov