About this trial
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 single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
Age 40-85 at diagnosis
Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
Disqualifiers
Pregnant or breastfeeding
Active collagen-vascular disease
Paget's disease of the breast
Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
Trial design
Single group
Treatments tested in this trial
Partial Breast Irradiation
Drug16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Treatment groups
Trial outcomes
Primary outcomes
Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205)
Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting.
Secondary outcomes
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12)
Cosmetic results at 1, 3, and 5 years after APBI, as assessed by The Breast Cancer Treatment Outcome Scale (BCTOS-12), a shortened, validated patient-reported outcome measure designed to assess aesthetic and functional outcomes after breast-conserving surgery. This is scored on a scale of 1-4 ("no difference" to "large difference"), where lower scores indicate better outcomes of satisfaction
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q)
The BREAST-Q radiation-specific module patient-reported outcome measure (PROM) that evaluates patient satisfaction with the cosmetic effects of radiation The Breast-Q is 6 questions and scored on a scale of 1-3 ("not at all" to "a lot") with lower scores indicating better outcomes of satisfaction.
Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
The Harvard Cosmesis Scale is a physician-rated form will be used by the radiation oncologist to score cosmesis with the following criteria: * Excellent: treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * Good: minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * Fair: significant radiation effects readily observable. * Poor: severe sequelae of breast tissue secondary to radiation effect.
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs
Digital photographs will be taken to visualize any potential changes in breast shape or contour. These will be taken by study staff utilizing the Radiation Oncology Department's designated camera. blindly analyzed by 2-3 radiation oncologists using the following 4-point numerical scale: * 4 (Excellent): the treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * 3 (Good): minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * 2 (Fair): significant radiation effects readily observable. * 1 (Poor): severe sequelae of breast tissue secondary to radiation effect. Photos will be uploaded to the digital study record. Analysis will be batched as study progresses. Each individual score as well as the average score will be entered into the electronic case report form (eCRF).
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