RecruitingPhase 2NCT06185205

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Sponsor

Virginia Commonwealth University

Enrollment

170 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Sex: FEMALEMin Age: 45 YearsMax Age: 79 Years

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

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