Recruiting
Phase 2

APBI

Sponsor:

Virginia Commonwealth University

Code:

NCT07654257

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Partial Breast Irradiation

Study Details

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

Study ID

NCT07654257

Start date

Oct 19, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2036

Anticipated

Primary completion date

Oct 31, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

134 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Partial Breast Irradiation

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

Interventions

Partial Breast Irradiation

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

Primary outcome measure

  • 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) [ Time Frame: Baseline through 30 days following treatment, up to 5 years. ]

Central Contacts and Locations

Central contacts

Massey IIT Research Operations

804-628-6430masseyepd@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Massey CTO Breast Team

804-828-5406masseyctbrst@vcu.edu

Principal Investigator:

Bridget Quinn, MD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Breast Cancer
  • Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.