Actively Recruiting
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Led by Proton Collaborative Group · Updated on 2025-09-09
132
Participants Needed
9
Research Sites
1143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
CONDITIONS
Official Title
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
- Must be female.
- Must be >= 50 years of age.
- Must have a life expectancy of at least 5 years based on age and co-morbidities.
- Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
- Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar or patient does not have microscopically multifocal tumor.
- For invasive tumors with extensive intraductal component, total tumor size must be 3.0 cm or less.
- Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.). If stage II, tumor size must be <= 3.0 cm. Invasive histology must have nodal stage pN0 by H&E stains on sentinel node biopsy or axillary lymph node dissection.
- Must have ER positive disease with ER/PR report available.
- For invasive tumors, HER2 testing must be performed (positive or negative acceptable).
- Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.
- If image guidance with daily cone beam CT with direct physician visual assessment is used, markers or clips in the surgical bed are recommended but not required.
- If cone beam CT imaging will NOT be used for image guidance, patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment if not previously done.
- If markers/clips were placed at surgery, treatment must start within 12 weeks after lumpectomy or re-excision.
- If markers were not placed at surgery and are needed, they must be placed within 6 weeks after surgery.
- If systemic chemotherapy was given, markers/clips must have been placed at surgery and simulation scans done within 6 weeks of chemotherapy completion.
- Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy.
You will not qualify if you...
- Previous history of ipsilateral invasive breast cancer or DCIS.
- Any clinical or radiographically suspicious nodes unless biopsy proven benign.
- Non-epithelial malignancies such as sarcoma or lymphoma.
- Suspicious residual microcalcifications on mammography of either breast unless negative for malignancy on pathology.
- Multicentric or bilateral disease unless biopsy of clinical abnormalities are negative.
- Lymphovascular space invasion on pathology specimen.
- Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.
- Prior radiation therapy to the ipsilateral breast or thorax.
- Paget's disease of the nipple.
- Histologic examination showing invasive lobular histology.
- Skin involvement.
- Breasts technically unsatisfactory for radiation treatment upon discretion of treating physician.
- Significant infection or other co-existing medical condition precluding protocol therapy such as pregnancy, HIV/AIDS, or collagen vascular diseases including systemic lupus erythematosus, scleroderma, or dermatomyositis.
- Known BRCA 1 or BRCA 2 mutation.
- Pregnant or lactating.
AI-Screening
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Trial Site Locations
Total: 9 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
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States, 60555
Actively Recruiting
4
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
McLaren Proton Therapy Center
Flint, Michigan, United States, 48532
Actively Recruiting
6
New York Proton Center
New York, New York, United States, 10035
Actively Recruiting
7
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States, 73142
Actively Recruiting
8
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Hampton University Proton Therapy Institute
Hampton, Virginia, United States, 23666
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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