Evaluating cosmetic outcomes of whole breast irradiation with a boost for early-stage breast cancer
Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
NA · University of Wisconsin, Madison · NCT06295744
This study is testing if a new type of radiation therapy can improve the appearance of the breast and overall experience for women with early-stage breast cancer after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06295744 on ClinicalTrials.gov |
What this trial studies
This study evaluates the cosmetic outcomes, patient-reported outcome measures (PROMs), and toxicities in women with early-stage breast cancer undergoing ultra-short whole breast irradiation (WBI) therapy combined with a simultaneous integrated boost (SIB). A total of 50 participants will be enrolled, all of whom will have non-metastatic invasive breast cancer or ductal carcinoma in situ (DCIS). Participants will undergo breast-conserving surgery followed by adjuvant radiation therapy, with assessments conducted at multiple follow-up points over a period of 60 months. The study aims to provide insights into the effectiveness and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with early-stage invasive breast cancer or DCIS who are undergoing breast-conserving surgery and are eligible for whole breast irradiation with a tumor bed boost.
Not a fit: Patients who have undergone mastectomy or have metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cosmetic outcomes and quality of life for women undergoing breast cancer treatment.
How similar studies have performed: Other studies have shown promising results with similar approaches to whole breast irradiation, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- UW Carbone Cancer Center — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Jessica Schuster, MD — UW Carbone Cancer Center
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early-stage Breast Cancer, Cosmesis, Simultaneous Integrated Boost, Whole Breast Irradiation