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Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Study acronym: Breast53
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2024 to Dec 2028
    • Study completion date: Oct 2026 to Dec 2029
    • Site contact updated
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2022 to Jul 11, 2022
    • Eligibility criteria expanded, about 32 words
    • Site details revised
    v3
  3. Start date: Mar 2022 to May 2022
    • Primary completion date: Nov 2024 to Dec 2024
    • Study completion date: Sep 2026 to Oct 2026
    • Secondary endpoints: details revised at 2 of 3 entries
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.
Trial Details
NCT Number NCT05288777
Lead Sponsor University of Virginia
Conditions
(from sponsor)		 Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Related terms Breast Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov