This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.
The study population will consist of 50 participants with non-metastatic, early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). Eligible patients will include those with a biopsy proven invasive breast cancer or DCIS, greater than or equal to 18 years of age, undergoing breast conserving surgery and adjuvant radiation therapy at UW Health with an indication for WBI with tumor bed boost. Selection need for boost and radiation treatment field design and pre-tx imaging are at the discretion of the treating provider. Accrual will occur over 5 years at UW Health. Participants will complete 5 treatment visits and 7 study visits over the course of approximately 5.5 years. Research-related outcome measures - MD assessments (e.g., cosmesis) PROMs, and AEs -- will be assessed prior to treatment start, at the 6-week follow-up visit, as well as at 12-, 24-, 36-, 48- and 60-month follow-up visits. Study participation ends after completion of the 60-month follow-up visit. Objective • To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB. Secondary Objectives * To assess PROMs via BREAST-Q in patients treated with ultra-short WBI with SIB. * To assess acute toxicities in patients treated with ultra-short WBI with SIB. * To assess late toxicities in patients treated with ultra-short WBI with SIB. * To assess ipsilateral breast tumor recurrence in patients treated with ultra-short WBI with SIB. * To assess overall survival (OS) in patients treated with ultra-short WBI with SIB.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
WBI with SIB delivered over 5 fractions
UW Carbone Cancer Center
Madison, Wisconsin, United States
RECRUITINGHarvard Breast Cosmesis Scale Score
4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.
Time frame: up to 2 years post-treatment (treatment ends up to 5 weeks on study)
Change in BREAST-Q Score
The BREAST-Q questionnaire is scored from 0-100 where higher scores indicate better outcomes in each of 5 domains: Psychosocial Well-Being, Sexual Well-Being, Cancer Worry, Fatigue, and Impact on Work.
Time frame: baseline, 6 weeks post-RT, 12 months post-RT, 24 months post-RT, 60 months post-RT (treatment ends up to 5 weeks on study)
Incidence of Acute Toxicities
Acute toxicities (including breast dermatitis, induration) will be assessed after final treatment within 90 days of radiation therapy completion using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: up to 90 days post-RT (treatment ends up to 5 weeks on study)
Incidence of Late Toxicities
Late toxicities (including induration, fibrosis, shrinkage, and telangiectasia) will be assessed greater than 90 days of radiation therapy completion using CTCAE version 5.0
Time frame: up to 60 months on study
Ipsilateral Breast Tumor Recurrence-Free Survival
Kaplan-Meier curves will be used to estimate ipsilateral breast tumor recurrence-free survival.
Time frame: up to 60 months on study
Overall Survival (OS)
Kaplan-Meier curves will be used to estimate OS.
Time frame: up to 60 months on study
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