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Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer

Study acronym: OlympiaN
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Results posted: Sep 25, 2026 · Trial completed · Study completion date changed from estimate of Dec 31, 2026 to Sep 16, 2025 · 3 more Show 6 more changesShow less
    • Results posted: Sep 25, 2026
    • Trial completed
    • Study completion date changed from estimate of Dec 31, 2026 to Sep 16, 2025
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (7)
    • Site details revised at 1 of 36 sites
  2. Primary endpoint revised Trial status: Active, Not Recruiting to Completed · Study sites: 37 to 36 · Study completion date changed from estimate of Dec 31, 2026 to Sep 16, 2025 · 1 morev17 Show 4 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Study sites: 37 to 36
    • Study completion date changed from estimate of Dec 31, 2026 to Sep 16, 2025
    • Secondary endpoints: 14 to 7

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since Jun 9, 2025, no change to tracked fieldsv15-v16
  4. Study sites: 44 to 37v14
  5. Primary completion date: May 2, 2024 to Nov 20, 2024 Enrollment target: 56 to 50 · Study sites: 62 to 44v13 Show 2 more changesShow less
    • Enrollment target: 56 to 50
    • Study sites: 62 to 44
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 50 to confirmed 56 · Study sites: 67 to 62 · Primary completion date: Apr 8, 2024 to May 2, 2024 · 1 morev12 Show 4 more changesShow less
    • Enrollment target: estimated 50 to confirmed 56
    • Study sites: 67 to 62
    • Primary completion date: Apr 8, 2024 to May 2, 2024
    • Completion date: Dec 7, 2026 to Dec 31, 2026
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites: 69 to 67v10
  4. Site details revised at 4 of 69 sitesv9
  5. Site details revised at 9 of 69 sitesv8
  6. Enrollment target: 80 to 50 Study sites: 65 to 69v7 Show 1 more changeShow less
    • Study sites: 65 to 69
  7. Study sites: 64 to 65v6
  8. Site details revised at 3 of 64 sitesv5
  9. Study sites: 61 to 64 Primary completion date: May 17, 2024 to Apr 8, 2024 · Completion date: Nov 20, 2026 to Dec 7, 2026v4 Show 2 more changesShow less
    • Primary completion date: May 17, 2024 to Apr 8, 2024
    • Completion date: Nov 20, 2026 to Dec 7, 2026
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 48 to 61 · Start date changed from estimate of Oct 21, 2022 to Nov 7, 2022v3 Show 2 more changesShow less
    • Study sites: 48 to 61
    • Start date changed from estimate of Oct 21, 2022 to Nov 7, 2022
  11. Start date: Sep 9, 2022 to Oct 21, 2022 Study sites: 7 to 48 · Primary completion date: Apr 5, 2024 to May 17, 2024 · Completion date: Oct 9, 2026 to Nov 20, 2026v2 Show 3 more changesShow less
    • Study sites: 7 to 48
    • Primary completion date: Apr 5, 2024 to May 17, 2024
    • Completion date: Oct 9, 2026 to Nov 20, 2026
  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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems. Olaparib is a type of drug called a PARP (poly \[adenosine diphosphate-ribose\] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy . Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.
Trial Details
NCT Number NCT05498155
Lead Sponsor AstraZeneca
Conditions Breast Cancer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov