Intraoperative Electron Radiation Therapy (IOERT) for Treatment of Breast Cancer

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In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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.

Contact Info:

Shannon Cyhan
cyhan.shannon@scrippsheatlh.org