Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Study ID
- NCT06902311
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Breast Cancer
- DCIS
- Ductal Carcinoma in Situ
- Early-stage Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Breast Radiotherapy — RADIATIONThe tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).
Study Details
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.
Key Dates
- Start date
- Feb 19, 2025
- Status verified
- Mar 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: WBI-SIBFive-fraction whole breast irradiation (WBI) with simultaneous integrated tumor bed boost (SIB).
Primary Outcome Measure
Rate of any moderate-marked adverse effects [ Time Frame: 1 year ]
Central Contacts
- Jessica Buddenbaum919-966-4432
- Cory Grreenwood919-445-4929
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | Dana Casey, MD (PRINCIPAL_INVESTIGATOR) |
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