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Active, Not Recruiting

NCT Number: NCT06295744

Outcomes and Cosmesis With Whole Breast Irradiation and Boost

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

WBI with SIB delivered over 5 fractions

Primary outcomes

  1. Harvard Breast Cosmesis Scale Score

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

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

Secondary outcomes

  1. Change in BREAST-Q Score

    Time frame: 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)

    The BREAST-Q questionnaire is scored from 0-100 where higher scores indicate better outcomes in each of 5 domains: Psychosocial Well-Being, Sexual Well-Being, Cancer Worry, Fatigue, and Impact on Work.

  2. Incidence of Acute Toxicities

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

    Acute toxicities (including breast dermatitis, induration) will be assessed after final treatment within 90 days of radiation therapy completion using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  3. Incidence of Late Toxicities

    Time frame: up to 60 months on study

    Late toxicities (including induration, fibrosis, shrinkage, and telangiectasia) will be assessed greater than 90 days of radiation therapy completion using CTCAE version 5.0

  4. Ipsilateral Breast Tumor Recurrence-Free Survival

    Time frame: up to 60 months on study

    Kaplan-Meier curves will be used to estimate ipsilateral breast tumor recurrence-free survival.

  5. Overall Survival (OS)

    Time frame: up to 60 months on study

    Kaplan-Meier curves will be used to estimate OS.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Mar 6, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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