Outcomes and Cosmesis With Whole Breast Irradiation and Boost

NCT ID: NCT06295744

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2032-02-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WBI with SIB

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

WBI with SIB delivered over 5 fractions

Interventions

Radiation Therapy

WBI with SIB delivered over 5 fractions

Intervention Type: RADIATION

Eligibility Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

UW Carbone Cancer Center

Locations

UW Carbone Cancer Center

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cancer Connect

Role: CONTACT

clinicaltrials@cancer.wisc.edu

800-622-8922

Other Identifiers

Protocol Version 11/14/2024

Identifier Type: OTHER

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

UW23114

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2024-01891

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-1724

Identifier Type: -

Identifier Source: org_study_id