Single FrAction Interstitial BreaSt BracHytherApy

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07654257
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Partial Breast Irradiation — DRUG
    16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Study Details

This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2036
Completion
Sep 30, 2036

Study Design

Enrollment
134 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Partial Breast Irradiation
    Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day

Primary Outcome Measure

Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) [ Time Frame: Baseline through 30 days following treatment, up to 5 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey CTO Breast Team
804-828-5406
Bridget Quinn, MD (PRINCIPAL_INVESTIGATOR)

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