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

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
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.

Treatment Experimental: WBI with SIB
Radiation: Radiation Therapy
WBI with SIB delivered over 5 fractions

Key Eligibility Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document

Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS

Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx

Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques

Treatment plan includes breast tumor bed boost

Willingness to comply with all study procedures and be available for the duration of the study

Mastectomy of ipsilateral breast

Lack of histologic diagnosis

Histologic involvement of the axillary or regional nodes or metastatic disease

Accelerated partial breast irradiation treatment plan

Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin

Previous history of chest radiation therapy

Previous history of ipsilateral breast cancer

Concurrent cytotoxic chemotherapy

Active connective tissue disease including scleroderma

Inability or unwillingness to return for required follow up visit

Applicable Disease Sites
Breast

Participating Institutions
Johnson Creek, UW Cancer Center; UW Health Eastpark Medical Center; UW Health University Hospital