Outcomes and Cosmesis With Whole Breast Irradiation and Boost

NCT06295744 | Active Not Recruiting FDA Device

• 5 other identifiers: 2023-1724Protocol Version 11/14/2024A533300UW23114NCI-2024-01891
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer

Keywords

Cosmesis; Simultaneous Integrated Boost; Whole Breast Irradiation

Outcome Measures

Primary Outcomes (1)

• Harvard Breast Cosmesis Scale Score

  4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.

  up to 2 years post-treatment (treatment ends up to 5 weeks on study)

Secondary Outcomes (5)

• Change in BREAST-Q Score

  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

  up to 90 days post-RT (treatment ends up to 5 weeks on study)

• Incidence of Late Toxicities

  up to 60 months on study

• Ipsilateral Breast Tumor Recurrence-Free Survival

  up to 60 months on study

• Overall Survival (OS)

  up to 60 months on study

Study Arms (1)

WBI with SIB

EXPERIMENTAL

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

WBI with SIB delivered over 5 fractions

WBI with SIB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jessica Schuster, MD

  UW Carbone Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)