ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

NCT06185205 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MCC-22-19248HM20027787
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course

  Determine the incidence of accelerated partial breast irradiation (APBI) related toxicities, adverse events, of interest occurring at grade ≥3 within 1 year and 3 years after APBI. The APBI-related toxicities specified in Section 10.1 will be explicitly evaluated at all follow-up appointments. All APBI-related toxicities of interest will be captured, regardless of grade, beginning with the start of study treatment and continuing until the patient is off study utilizing study-specific grading criteria in place of Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  1 year, and 5 years following irradiation

Secondary Outcomes (8)

• Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale.

  Baseline, one year, three years, and five years following irradiation

• Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale.

  Baseline, one year, three years, and five years following irradiation

• Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the BREAST-Q©.

  Baseline, one year, three years, and five years following irradiation

• Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Harvard Cosmesis Scale

  Baseline, one year, three years, and five years following irradiation

• Determine the 3- and 5-year actuarial local control rate of breast cancer when treated with a 1.5-day course of APBI.

  up to three and five years after irradiation

Study Arms (1)

Accelerated Partial Breast Irradiation (APBI)

EXPERIMENTAL

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Drug: Accelerated partial breast irradiation

Interventions

Accelerated partial breast irradiation DRUG

High Dose Rate treatment delivery

Accelerated Partial Breast Irradiation (APBI)

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Bridget Quinn, MD, Ph.D

  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

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2033
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)