Single FrAction Interstitial BreaSt BracHytherApy (SASHA)
Virginia Commonwealth University
Summary
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.
Eligibility
- Age range
- 40–85 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female * New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation * Age 40-85 at diagnosis * Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist * T stage of Tis, T1, or T2 * T2 tumors must be ≤3 cm in maximum diameter * If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy * For patients with invasive breast cancer, an axillary staging procedure must be…
Interventions
- DrugPartial Breast Irradiation
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Location
- Virginia Commonwealth UniversityRichmond, Virginia