Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.

Inclusion Criteria:

• Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
• Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
• Life expectancy > 12 months

Exclusion Criteria:

• Pregnant or breast-feeding
• Prior therapeutic radiation > 200 cGy
• History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
• Prior investigation chemotherapy