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Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen

Study acronym: APBI RISE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Phase: Not applicable to Phase 2v4 Show 6 more changesShow less
    • Primary completion date: Aug 31, 2024 to Jun 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 31, 2027 to Jun 2027
    • Start date: Mar 1, 2022 to Mar 30, 2022
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised at 2 of 2 sites
  3. Study sites: 3 to 2
    • Primary completion date: Mar 31, 2024 to Aug 31, 2024
    • Study description shortened, about 28 words
    • Study title shortened, about 7 words
    v3
  4. Secondary endpoints revised (6)v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.
Trial Details
NCT Number NCT05591547
Lead Sponsor Sanford Health
Collaborators: University of North Dakota
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov