Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Virginia Commonwealth University1 site in 1 country170 target enrollmentDecember 12, 2023

ConditionsBreast Cancer

InterventionsAccelerated partial breast irradiation

DrugsAccelerated partial breast irradiation

Overview

Phase: Phase 2
Intervention: Accelerated partial breast irradiation
Conditions: Breast Cancer
Sponsor: Virginia Commonwealth University
Enrollment: 170
Locations: 1
Primary Endpoint: Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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 short course over 1.5 days

Registry

clinicaltrials.gov

Start Date

December 12, 2023

End Date

January 31, 2033

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Virginia Commonwealth University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 T
•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

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

Arms & Interventions

Accelerated Partial Breast Irradiation (APBI)

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Intervention: Accelerated partial breast irradiation

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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)
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1.5-day course of APBI(up to five years after irradiation)
Conduct detailed evaluation of the severity of punctate scarring at 5 weeks, 6 months, and yearly through 5 years after a 1.5-day course of APBI(5 weeks, 6 months, and yearly through 5 years following irradiation)
Assess rates of skin changes after a 1.5-day course of APBI in African American and non-African American patients.(5 weeks, 6 months, and yearly through 5 years following irradiation)