- Trial ID:
- IRB-16-6866
- Ken Shimizu, MD
The goal of this study is to evaluate if a single dose of electron radiation therapy delivered during breast conserving surgery is safe and effective for treating patients with early stage breast cancer. Surgery and radiation treatment will occur in the operating room at Scripps Memorial La Jolla on the same day. Patients will be followed after surgery at 1, 3, 6, 9 and 12 months, and then every 6 months after that for up to 5 years.
Inclusion Criteria
- Be a women age 50 or older
- Have a diagnosis of unifocal (unicentric), invasive or in situ ductal carcinoma and/or invasive mammary carcinomas, less than 2.5cm in diameter, grade 1, 2, or 3
- Agree to breast conservation therapy as the local treatment for the breast cancer
- Agree to a sentinel lymph node biopsy
- Be negative for BRCA1 and 2 gene mutation, if testing is indicated
- Meet all other eligibility criteria
Exclusion Criteria
- Have a previous diagnosis of breast cancer or other metastatic cancer
- Have a diagnosis of triple negative breast cancer
- Have received neoadjuvant chemotherapy
- Have a compromised immune system
- Have a pacemaker present in the field of radiation or quadrant of the breast cancer
- Be pregnant or attempting to get pregnant
- Be ineligible for breast conserving surgery
Additional Info
- Single dose IOERT is not typically used as a stand-alone therapy for patients with early stage breast cancer; external beam radiation therapy is also usually required after surgery.
- Single dose IOERT programs are currently being conducted at several cancer centers within the United States. Published studies have shown that single dose IOERT as a stand-alone treatment is safe and effective for selected breast cancer patients; however, no criteria for treatment or results have been reported yet.