Single FrAction Interstitial BreaSt BracHytherApy

NCT07654257 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MCC-25-22764HM300001026
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Radiation

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

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

Secondary Outcomes (6)

• 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)

  Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment

• 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)

  Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment

• Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale

  Baseline, 6 months, then annually up to 5 years following treatment

• 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

  Baseline, 5 weeks, 6 months, annually up to 5 years following treatment

• Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)

  Baseline, up to 5 years following treatment

Study Arms (1)

Partial Breast Irradiation

EXPERIMENTAL

Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day

Drug: Partial Breast Irradiation

Interventions

Partial Breast Irradiation DRUG

16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Also known as: Brachytherapy

Partial Breast Irradiation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• New diagnosis of 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 HER2-positive, the patient is planning to receive or has already received HER2-directed therapy
• Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
• ≥70 years of age
• ER+, 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:
• years of age
• Grade 1-2 breast cancer

You may not qualify 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 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Bridget Quinn, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2036
• Study Completion (Estimated): September 30, 2036
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)