A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
- 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
- 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.
- Arm II: Patients undergo lumpectomy only. Patients are followed at 30 and 90 days after
surgery, and then at the discretion of the physician.
PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued
for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
William E. Gannon, MD
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Oklahoma University Medical Center at University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73126|
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Seattle, Washington 98195|
|Comprehensive Breast Center of Coral Springs||Coral Springs, Florida 33071|
|Mroz-Baier Breast Care Center||Memphis, Tennessee 38119|
|Breast Care Specialists, P.C.||Norfolk, Virginia 23510|