A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast

OBJECTIVES:

• Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer.
• Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens.
• Compare the percentage of pathological cell death in women treated with these regimens.
• Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens.
• Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor classification (T1 vs T2) and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I:Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of undue heating of the skin, a tumor temperature of 48-52° C is targeted and maintained for an equivalent thermal dose of 140-180 minutes.

Within 60 days of thermotherapy, patients undergo lumpectomy.