Actively Recruiting
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-03-30
90
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and HIPAA authorization for personal health information release
- Female, age 50 years or older
- Confirmed invasive breast carcinoma or ductal carcinoma in situ
- Completed breast-conserving surgery with or without sentinel lymph node biopsy or axillary lymph node dissection
- Planned to receive standard whole breast 3D conformal radiation therapy or intensity modulated radiation therapy with standard dose tumor bed boost
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
- Enrollment in another clinical trial allowed if no intervention interference per Principal Investigator
You will not qualify if you...
- Concurrent breast reduction surgery involving tissue rearrangement in the lumpectomy cavity
- Synchronous bilateral breast cancer requiring radiation to both breasts
- Clinical or imaging evidence of distant metastases
- Prior radiation to the same breast or chest area
- Autoimmune conditions
- Collagen vascular diseases such as systemic lupus erythematosus, scleroderma, or dermatomyositis
- Tumors classified as pT4
- Recommended to receive regional nodal irradiation with associated radiation risks
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
J
Jessica Buddenbaum
CONTACT
C
Cory Grreenwood
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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