Actively Recruiting
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Led by University of Utah · Updated on 2025-12-09
144
Participants Needed
1
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
CONDITIONS
Official Title
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participant aged 18 years or older
- Histologically confirmed invasive carcinoma or ductal carcinoma in situ (DCIS) of the breast
- Breast cancer stage T0-3, N0, M0 according to AJCC v8, with T0 N0 allowed if whole breast radiation is recommended
- Lumpectomy performed within 84 days before starting radiation therapy
- ECOG Performance Status 0 to 2 or Karnofsky Performance Status 50 or higher
- Negative inked histologic margins from lumpectomy, except for a positive margin at the pectoralis fascia
- Negative pregnancy test for participants of childbearing potential, or evidence of permanent sterilization or post-menopausal status defined by specific hormone and menstrual criteria
- Sexually active participants of childbearing potential must agree to use a highly effective contraception method during and for 30 days after radiation
- At least one risk factor such as grade 3 invasive histology, estrogen receptor positivity less than 5%, lymphovascular invasion, invasive margins less than 2 mm, DCIS final positive margin, extensive intraductal component, age 50 years or younger, or tumor size greater than 2 cm
- Ability to provide informed consent and willingness to sign consent form
You will not qualify if you...
- Bilateral breast cancer
- Prior radiation therapy to the chest
- Prior chemotherapy
- Recurrent disease
- Known metastases or node positive disease
- Major chest surgery expected to impact participation within 8 weeks before starting study treatment
- Prior breast malignancy in either breast
- Diagnosis of another malignancy likely to affect safety or participation
- Uncontrolled significant illness including serious cardiac conditions, recent stroke, myocardial infarction, or thromboembolic events within 3 months
- Any condition contraindicating study participation due to safety or compliance concerns
- Significant post-lumpectomy complications requiring unplanned surgery or intravenous antibiotics
- Breast neuroendocrine carcinoma or sarcoma histology
- Radiation sensitizing diseases or conditions (e.g., connective tissue disease, Li-Fraumeni syndrome)
- Medical, psychiatric, cognitive, or other conditions impairing ability to consent or comply
- Use of concurrent radiation sensitizing medications or therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
D
David Samuel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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