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Recruiting
NCT06295744
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
Conditions: Early-stage Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University of Wisconsin, Madison
Location: UW Carbone Cancer Center Madison Wisconsin
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.
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
Source: ClinicalTrials.gov (NCT06295744). StuddyBuddy aggregates publicly available trial information.