Actively Recruiting
Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
Led by Proton Collaborative Group · Updated on 2025-09-09
276
Participants Needed
7
Research Sites
880 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
CONDITIONS
Official Title
Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with Stage I-III breast cancer who had breast conserving surgery or mastectomy and are recommended for radiation to the breast/chest wall and regional lymph nodes
- Histologically confirmed breast cancer types including invasive mammary, ductal, medullary, tubular, mucinous, lobular, or ductal carcinoma in situ
- Negative metastatic workup by whole body PET/CT or combined CT of chest, abdomen, pelvis and bone scan
- History and physical exam done within 90 days before study registration
- ECOG performance status of 0, 1, or 2
- Negative pregnancy test for women who can become pregnant
- Able to start radiation treatment within 12 weeks after last surgery or chemotherapy
- Use of breast implants, expanders, tissue flaps, or reconstruction allowed
- Bilateral breast cancer allowed if at least one side receives comprehensive nodal irradiation per protocol
You will not qualify if you...
- Presence of skin ulceration, ipsilateral satellite nodules, or edema (T4b or T4c disease) or inflammatory breast cancer (T4d disease)
- Residual gross disease except small (<2cm) internal mammary or supraclavicular lymph nodes eligible for boost
- Prior radiation therapy overlapping current treatment area
- Prior explant surgery or implant removal due to infection or wound healing issues without subsequent reconstruction
- Presence of double/dual port tissue expander
- Evidence of distant metastatic disease
- Pregnant or breastfeeding women
- Non-malignant systemic disease preventing treatment or follow-up
- History of connective tissue disorders such as lupus, scleroderma, dermatomyositis, xeroderma pigmentosum
- Known BRCA1 or BRCA2 mutation
- Active skin rash present
- Prior invasive non-study cancer unless disease-free for 3 or more years, except certain low-risk cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
California Protons Cancer Therapy Center
San Diego, California, United States, 92121
Actively Recruiting
3
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Actively Recruiting
4
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
5
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
New York Proton Center
New York, New York, United States, 10035
Actively Recruiting
7
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
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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