Recruiting
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
ClinicalTrials.gov IDNCT06185205
PhasePHASE2
Enrollment170
SponsorVirginia Commonwealth University
Age45 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
Interventions
- Drug: Accelerated partial breast irradiation — High Dose Rate treatment delivery
Primary outcomes
- Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course (1 year, and 5 years following irradiation)
Eligibility information
Inclusion Criteria:
* Female
* New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 45-79 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 2 (HER2)-positive, the patient must receive HER2-directed therapy.
* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative.
* Note: N0(i+) is not an exclusion criterion.
* Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
* ≥70 years of age
* estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
* G1-2
* Tumor ≤2 cm in size
* Agrees to comply with aromatase inhibitor recommendation
* Ability to understand and the willingness to sign a written informed consent document in English
Exclusion Criteria:
* Pregnant or breastfeeding
* Active collagen-vascular disease
* Paget's disease of the breast
* History of DCIS or invasive breast cancer prior to the current diagnosis
* Prior breast or thoracic radiation therapy (RT) for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive
* Excision cavity that cannot be clearly delineated per the treating investigator
* Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol and will come off the study. Any subsequent adjuvant radiation will be delivered at the discretion of the treating physician
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Study locations
- Virginia Commonwealth University, Richmond, Virginia 23298 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.