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Outcomes and Cosmesis With Whole Breast Irradiation and Boost

Early-stage Breast Cancer Clinical Trial

Official title:
Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06295744
Study type Interventional
Source University of Wisconsin, Madison
Contact Cancer Connect
Phone 800-622-8922
Email clinicaltrials@cancer.wisc.edu
Status Recruiting
Phase N/A
Start date April 17, 2024
Completion date February 2032
View Details
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