Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
UNC Lineberger Comprehensive Cancer Center
Summary
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.
Description
Multiple recent studies demonstrate the noninferiority of a simultaneous integrated boost (SIB) approach. This study will include women aged 50 years and older who are recommended to receive whole breast irradiation with a standard dose boost and without regional nodal irradiation. Radiation therapy will consist of 5 fractions delivered every other day (excluding weekends), with a total dose of 26 Gy to the whole breast and a simultaneous integrated boost to a total dose of 30 Gy to the lumpectomy cavity. The primary outcome of this study is to investigate the rate of moderate to marked adve…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- No
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria: * Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ. * Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). * Subjects planned to receive either SOC whole breast 3…
Interventions
- RadiationBreast Radiotherapy
The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).
Location
- University of North CarolinaChapel Hill, North Carolina