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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
134
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Virginia Commonwealth University
Richmond, Virginia, United States
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.
Time frame: Baseline through 30 days following treatment, up to 5 years.
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
Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
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.
Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
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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.
Time frame: Baseline, 6 months, then annually up to 5 years following treatment
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).
Time frame: Baseline, 5 weeks, 6 months, annually up to 5 years following treatment
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)
Incidence of treatment-related breast toxicities of interest occurring at any grade within 5 years after APBI. Toxicities will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.
Time frame: Baseline, up to 5 years following treatment
Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI
Disease control will be assessed by physical examination and mammography. All cases of local failure must be confirmed using pathologic criteria established by Recht et al will be used to help classify the type of local in-breast recurrence as follows: * True Recurrence/Marginal Miss (TR/MM) Failure: a recurrence of the treated cancer within or immediately adjacent to the primary tumor site. * Elsewhere (E) Failure: local recurrence several centimeters from the primary site and is generally believed to be a new primary cancer. Classification of the failure type is at the discretion of the treating investigator.
Time frame: 1 year, 3 years, and up to 5 years following treatment