ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Official title

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Overview

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

Interventions

• Drug Accelerated partial breast irradiation
  High Dose Rate treatment delivery

Primary outcome measures

• 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]

Secondary outcome measures (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. [Time frame: 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. [Time frame: 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©. [Time frame: 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 [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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. [Time frame: 5 weeks, 6 months, and yearly through 5 years following irradiation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06185205 · MCC-22-19248 · HM20027787

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗