Study on Proton Radiation for Stage II/III Breast Cancer
Sponsor: Proton Collaborative Group
ClinicalTrials ID:NCT01758445
This clinical trial is examining the safety and long-term effects of using proton radiation therapy after surgery in women with advanced breast cancer. The study will track heart health and the risk of developing new cancers over 10 to 15 years.
Patient Parameters
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Program Overview
The aim of this study is to evaluate the safety and effectiveness of proton radiation therapy for women with advanced breast cancer who have had surgery. Proton therapy is believed to better target cancer cells while reducing radiation exposure to the heart, lungs, and the other breast. The study will follow participants for up to 15 years to monitor heart health and the risk of developing new cancers.
Description
This Phase II study is building on previous research that showed proton therapy can better target cancer cells and reduce radiation exposure to the heart and other areas compared to traditional radiation. The goal is to show that proton therapy can reduce heart problems and the risk of developing a new cancer in the other breast. These benefits are important because traditional radiation can sometimes affect the heart and lead to new cancers. The study will involve long-term follow-up to gather data on these outcomes, despite the challenges of tracking patients over many years. The research is based on strong evidence that proton therapy can minimize or even eliminate radiation exposure to the heart and other areas, which is a unique advantage of this treatment.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form to participate in the study.
- Must be 18 years or older.
- Must have a life expectancy of at least 10 years, not counting the breast cancer diagnosis.
- Must have a confirmed diagnosis of invasive ductal or lobular breast cancer.
- Must be at Stage II or III according to specific medical guidelines.
- Must have had surgery to remove the breast cancer, either a mastectomy or breast-conserving surgery like a lumpectomy. Additional surgery to clear cancer margins is allowed.
- Multicentric breast cancer and Paget's disease of the nipple are allowed.
Exclusion Criteria
- Weigh more than 410 pounds.
- Have non-epithelial breast cancers like sarcoma or lymphoma.
- Have surgical margins that cannot be assessed or are positive for cancer, unless cleared by additional surgery.
- Have a breast size that makes daily treatment setup difficult, as determined by the treatment center.
- Have temporary breast expanders after surgery, which require individual assessment for eligibility.
- Have a history of breast cancer.
- Have had previous radiation to the breast or chest area.
- Have certain autoimmune diseases like dermatomyositis, lupus, or scleroderma.
- Are pregnant or breastfeeding. Women who can become pregnant must use effective non-hormonal birth control during treatment and have a negative pregnancy test before starting the study.
- Have psychiatric or addiction issues that would prevent meeting study requirements.
- Have had other cancers unless they have been cancer-free for 5 years and are considered low risk for recurrence. Exceptions include certain non-invasive cancers treated in the last 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern Medicine Chicago Proton Center | 60555 | Warrenville | Illinois |
| Maryland Proton Treatment Center | 21201 | Baltimore | Maryland |
| Princeton ProCure Managment LLC | 08873 | Somerset | New Jersey |
| Oklahoma Proton Center | 73142 | Oklahoma City | Oklahoma |
| Hampton University Proton Therapy Institute | 23666 | Hampton | Virginia |
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