Status and phase
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About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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:
Ability to understand and the willingness to sign a written informed consent document in English
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
120 participants in 1 patient group
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Central trial contact
Massey IIT Research Operations
Data sourced from clinicaltrials.gov
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