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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
High Dose Rate treatment delivery
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGAssess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
Determine the incidence of accelerated partial breast irradiation (APBI) related toxicities, adverse events, of interest occurring at grade ≥3 within 1 year and 3 years after APBI. The APBI-related toxicities specified in Section 10.1 will be explicitly evaluated at all follow-up appointments. All APBI-related toxicities of interest will be captured, regardless of grade, beginning with the start of study treatment and continuing until the patient is off study utilizing study-specific grading criteria in place of Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: 1 year, and 5 years following irradiation
Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale.
Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the aesthetic outcome after breast conserving surgery (BCS). the Aesthetic Status, is composed of eight items referring to the breast. the new Aesthetic Status comprises eight items: (1) "breast shape", (2) "breast texture", (3) "nipple appearance", (4) "breast tenderness", (5) "scar tissue", (6) "breast swelling", (7) "fit of bra", and (8) "breast sensitivity". Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast (1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.
Time frame: Baseline, one year, three years, and five years following irradiation
Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale.
Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the functional outcome after breast conserving surgery (BCS). The questionnaire comprises 12 items and assesses various aspects of patients' subjective perception of the surgical result. The new Functional Status comprises four items: (1) "arm heaviness", (2) "shoulder discomfort", (3) "arm discomfort", (4) "arm swelling". Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast (1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.
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Time frame: Baseline, one year, three years, and five years following irradiation
Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the BREAST-Q©.
The radiation-specific module of this patient-reported outcome measure evaluates patient satisfaction with the cosmetic effects of radiation by utilizing the BREAST-Q© (intellectual property of Drs Andrea Pusic, Anne Klassen and Stefan Cano. The BREAST-Q© is owned by Memorial Sloan Kettering Cancer Center and The University of British Columbia (Copyright ©2012, Memorial Sloan Kettering Cancer Center and The University of British Columbia). There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL.
Time frame: Baseline, one year, three years, and five years following irradiation
Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Harvard Cosmesis Scale
This physician-rated form will be used by the treating surgeon or radiation oncologist to score cosmesis at baseline and annually for 5 years, where 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, one year, three years, and five years following irradiation
Determine the 3- and 5-year actuarial local control rate of breast cancer when treated with a 1.5-day course of APBI.
The number of participants that achieve complete responses, partial response, or relapse. Disease control will be assessed by physical examination and mammography.
Time frame: up to three and five years after irradiation
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1.5-day course of APBI
The number of participants that have a reportable adverse event (AE) per protocol criteria.
Time frame: up to five years after irradiation
Conduct detailed evaluation of the severity of punctate scarring at 5 weeks, 6 months, and yearly through 5 years after a 1.5-day course of APBI
Incidence and grade of punctate scarring. Punctate scarring, defined as scarring from catheter sites, is assigned according to the following grading criteria (Table 5): * No toxicity: not clearly visible from 3 feet away * Grade 1a: clearly visible from 3 feet away and no palpable scars * Grade 1b: clearly visible from 3 feet away and palpable scars at \<25% of catheter sites) OR clearly visible at 3-10 feet and no palpable scar tissue * Grade 1c: clearly visible from ≥10 feet away and no palpable scars OR clearly visible at \<10 feet and palpable scars at \<25% of catheter sites) * Grade 2: prominent (ie, visible at ≥10 feet away) and palpable scar tissue
Time frame: 5 weeks, 6 months, and yearly through 5 years following irradiation
Assess rates of skin changes after a 1.5-day course of APBI in African American and non-African American patients.
Incidence of skin changes after APBI in African American and non-African American patients.
Time frame: 5 weeks, 6 months, and yearly through 5 years following irradiation