NCT06295744

Outcomes and Cosmesis With Whole Breast Irradiation and Boost

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Early-stage Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	WBI with SIB delivered over 5 fractions

Timeline

• Start date: 2024-04-17
• Primary completion: 2029-02-01
• Completion: 2032-02-01
• First posted: 2024-03-06
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study