Recruiting
Phase 2

Radiation Treatment

Sponsor:

Virginia Commonwealth University

Code:

NCT06185205

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Accelerated partial breast irradiation

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT06185205

Start date

Dec 12, 2023

Status verified date

Nov, 2025

Completion date

Jan 31, 2033

Anticipated

Primary completion date

Jan 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 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 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 Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated Partial Breast Irradiation (APBI)

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Interventions

Accelerated partial breast irradiation

High Dose Rate treatment delivery

Primary outcome measure

  • Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course [ Time Frame: 1 year, and 5 years following irradiation ]

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

804-628-6430masseyctbrst@vcu.edu

Principal Investigator:

Bridget Quinn, MD, Ph.D

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • Breast Cancer
  • Ductal Carcinoma in situ (DCIS)
  • Irradiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-11-21.