Single Fraction Interstitial Breast Brachytherapy for Breast Cancer

This study is looking at a new way to deliver radiation therapy for breast cancer called Single FrAction Interstitial BreaSt BracHytherApy. This treatment involves giving a single dose of radiation (16 Gy) over one day directly into the breast using special catheters. The main goal is to see how safe this treatment is and compare any side effects to those seen in other similar studies. You might be able to join if you are a woman between 40 and 85 years old with a new diagnosis of certain types of breast cancer (Ductal Carcinoma in Situ or invasive breast carcinoma) and have already had a lumpectomy. The study is currently unclear about its recruitment status.

Study design: This is a Phase 2 study involving about 134 women. It is a single-arm study, meaning all participants will receive the same treatment.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be monitored for side effects from the start of treatment through 30 days after, and then for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Single FrAction Interstitial BreaSt BracHytherApy

Not Yet Recruiting

PHASE2Ages 40–85InterventionalTreatment

Virginia Commonwealth University

~134 participants

Updated 2026-06-18 on ClinicalTrials.gov

What's tested:Partial Breast Irradiation

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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)

Measured over Baseline through 30 days following treatment, up to 5 years.

Conditions

Breast Cancer

Where it's being run

1 sites across 1 states

Virginia1

Study leadership

Bridget Quinn, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Massey IIT Research Operations

[email protected]

804-628-6430

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

≥70 years of age

Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2-

Grade 1-2 breast cancer

Tumor ≤2 cm in size

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

Exclusion

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

What this trial measures

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.
Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting.

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