NCT06295744 · University of Wisconsin, Madison
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
Radiation Therapy
WBI with SIB delivered over 5 fractions
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations