Single FrAction Interstitial BreaSt BracHytherApy

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age40 Years to 85 Years
• SexFemale
• Healthy volunteersNo

You may be able to join if

• 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 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 (ER)+, progesterone receptor (PR)+/-, HER2-
• Grade 1-2 breast cancer
• Tumor ≤2 cm in size
• Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:
• 50-69 years of age
• Grade 1-2 breast cancer
• Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI)
• ER+, PR+, HER2-
• Tumor ≤2 cm in size
• Agrees to comply with aromatase inhibitor recommendation
• Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy
• Ability to understand and the willingness to sign a written informed consent document

You cannot join if

• Pregnant or breastfeeding
• Active collagen-vascular disease
• Paget's disease of the breast
• Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
• Any prior history of breast radiation therapy (RT) or thoracic 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
• Treatment with neoadjuvant chemotherapy
• Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator
• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Partial Breast Irradiation (Drug): 16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Na · Single Group · masking: None

Main goals

• Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) (Baseline through 30 days following treatment, up to 5 years.)

Other goals

• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12)
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q)
• Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs
• Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)
• Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI

Planned enrollment: 134 (estimated).

• Virginia Commonwealth University, Richmond, Virginia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07654257

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 22, 2026. Public record; not medical advice.