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
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating proton radiation therapy as a treatment option for women with early stage breast cancer. This study aims to compare the effects, both positive and negative, of proton therapy against traditional radiation methods. The focus is on whether limiting radiation to the original tumor area, rather than the whole breast, can reduce side effects and improve convenience and cost without compromising treatment effectiveness. The study involves delivering proton radiotherapy at a dose of 4.0 Gy (RBE) per session across 10 sessions, totaling 40 Gy (RBE). This partial breast irradiation approach targets the tumor area specifically, potentially minimizing radiation exposure to surrounding healthy breast tissue. The treatment is non-invasive and uses advanced imaging guidance, with some patients possibly requiring markers placed in the surgical area to assist with accurate targeting. Participants start treatment within 12 weeks of surgery or 8 weeks after chemotherapy completion. Participants will be closely monitored through regular assessments every six months, including evaluations of breast cancer recurrence, treatment-related toxicity, dosimetry related to breast size, quality of life, and overall survival, with key outcomes reviewed at three years. Safety and effectiveness are continuously assessed, and participants' health status will be followed long-term. The total duration of involvement varies as lifetime follow-up is planned for toxicity and quality of life measures.
CONDITIONS
Brief 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 be female.
- Must be 50 years of age or older.
- Must have a life expectancy of at least 5 years based on age and co-morbidities.
- Must have pathology proven invasive ductal carcinoma or ductal carcinoma in situ (DCIS).
- Tumors that are microscopically multifocal must be 3.0 cm or less in total size and within a single scar, or patient must not have multifocal tumors.
- For invasive tumors with extensive intraductal component, total tumor size must be 3.0 cm or less.
- Must be Stage 0, I, or II breast cancer with tumor size 3.0 cm or less and nodal stage pN0 if invasive.
- Must have estrogen receptor positive disease with ER/PR report available.
- HER2 testing must be performed for invasive tumors.
- Must have had a lumpectomy with negative margins of 0.2 cm or more.
- If image guidance with cone beam CT is used, markers or clips are recommended; if not used, at least 2 fiducial markers must be placed prior to treatment.
- Must be able to start treatment within 12 weeks after surgery or 8 weeks after finishing chemotherapy.
You will not qualify if you...
- Previous history of invasive breast cancer or DCIS in the same breast.
- Suspicious lymph nodes unless biopsy confirmed benign.
- Non-epithelial malignancies such as sarcoma or lymphoma.
- Suspicious residual microcalcifications on mammography unless proven benign.
- Multicentric or bilateral disease without negative biopsy of abnormalities.
- Presence of lymphovascular space invasion on pathology.
- Prior radiation therapy to the same breast or thorax.
- Paget's disease of the nipple.
- Invasive lobular carcinoma histology.
- Skin involvement by cancer.
- Breasts unsuitable for radiation treatment per physician discretion.
- Significant infection or medical conditions like pregnancy, HIV/AIDS, or certain collagen vascular diseases.
- Known BRCA1 or BRCA2 mutation.
- Pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive proton radiotherapy delivering 4.0 Gy (RBE) per fraction over 10 fractions to a total dose of 40 Gy (RBE) targeting the tumor region after lumpectomy.
10 daily visits for treatment
Duration - Up to 3 years
Participants are monitored for safety, toxicity, recurrence, and quality of life after completing proton therapy.
Visits approximately every 6 months for assessments
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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