Status:
RECRUITING
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-79 years
Phase:
PHASE2
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2033
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06185205
Start Date
December 12 2023
End Date
January 31 2033
Last Update
November 21 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298