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BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer

Study acronym: BRE-04
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from May 2026 to May 2027v12
  2. Eligibility criteria revised Site contact updatedv11 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv10
  4. Primary and study completion dates: May 2024 to May 2026 Eligibility criteria revised · Site contact updatedv9 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 2 to 1 Eligibility criteria expanded, about 16 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: May 2023 to May 2024 Start date changed from estimate of Dec 31, 2021 to Jan 10, 2022v6 Show 1 more changeShow less
    • Start date changed from estimate of Dec 31, 2021 to Jan 10, 2022
  3. Start date: Oct 2021 to Dec 31, 2021v5
  4. Start date: Jul 2021 to Oct 2021v4
  5. Start date: May 2021 to Jul 2021v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2v2 Show 1 more changeShow less
    • Study sites: 1 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.
Trial Details
NCT Number NCT04891068
Lead Sponsor University of Illinois at Chicago
Conditions Breast Cancer Invasive, Early-stage Breast Cancer, High Risk Breast Carcinoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov