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Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

Study acronym: Subito
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv20
  2. Primary completion date changed from estimate of Jul 1, 2025 to Jul 18, 2024v19
  3. Primary completion date: Oct 1, 2024 to Jul 1, 2025v18
  4. Primary endpoint revised Secondary endpoints: 5 to 7v17 Show 1 more changeShow less
    • Secondary endpoints: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Apr 2024 to Oct 1, 2024 Completion date: Dec 2029 to Dec 1, 2033v16 Show 1 more changeShow less
    • Completion date: Dec 2029 to Dec 1, 2033
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2023 to Apr 2024 · Site details revised at 11 of 11 sitesv15 Show 2 more changesShow less
    • Primary completion date: Dec 2023 to Apr 2024
    • Site details revised at 11 of 11 sites
  2. 2 versions Re-verified since Oct 11, 2022, no change to tracked fieldsv13-v14
  3. Primary completion date: Dec 2022 to Dec 2023v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date: Dec 2021 to Dec 2022 Site details revised at 1 of 11 sitesv10 Show 1 more changeShow less
    • Site details revised at 1 of 11 sites
  6. 2 versions Re-verified since Sep 21, 2020, no change to tracked fieldsv8-v9
  7. Primary completion date: Dec 2019 to Dec 2021 Study sites: 12 to 11v7 Show 1 more changeShow less
    • Study sites: 12 to 11
  8. Start date: Aug 2016 to Jan 25, 2017 Primary completion date: Aug 2019 to Dec 2019 · Completion date: Aug 2029 to Dec 2029 · Site details revised at 4 of 12 sitesv6 Show 3 more changesShow less
    • Primary completion date: Aug 2019 to Dec 2019
    • Completion date: Aug 2029 to Dec 2029
    • Site details revised at 4 of 12 sites
  9. Site details revised at 2 of 12 sitesv5
  10. Site details revised at 1 of 12 sitesv4
  11. Trial status: Active, Not Recruiting to Recruiting Site details revised at 12 of 12 sitesv3 Show 1 more changeShow less
    • Site details revised at 12 of 12 sites
  12. Trial status: Not Yet Recruiting to Active, Not Recruiting Site contacts updated at 12 of 12 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 12 of 12 sites
  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.
Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.
Trial Details
NCT Number NCT02810743
Lead Sponsor The Netherlands Cancer Institute
Conditions Breast Cancer
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov