ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

• Status: Recruiting
• Trial end date: 2033-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University

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