Trial Information

A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-Operative Focused Microwave Thermotherapy Treatment Combined With Pre-Operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast

OBJECTIVES:

- Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive
doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in
women with locally advanced breast cancer in an intact breast.

- Evaluate percentage of patients who achieve at least 85% pathological cell death after
treatment with focused microwave thermotherapy.

- Compare clear pathology tumor margins and reduction of second incision rates in
patients treated with these regimens.

- Compare the amount of surgically removed breast and tumor tissue in patients treated
with these regimens.

- Compare the measurement of the extent of tumor margins in patients treated with these
regimens.

- Compare the reduction of tumor size in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to tumor size (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15
minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of
unacceptable toxicity.

During courses 1 and 2 only, patients undergo focused microwave thermotherapy on day 1 of
chemotherapy (or within 36 hours after chemotherapy). 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 any unacceptable toxicity, a target tumor temperature of 43-47° C is reached
and maintained for an equivalent thermal dose of 80-120 minutes.

- Arm II: Patients receive chemotherapy only as in arm I. Within 60 days after completion
of thermochemotherapy or chemotherapy alone, patients in both arms undergo total
mastectomy, partial mastectomy, or other breast-conserving surgery, as appropriate. At
the discretion of the physician, beginning after completion of chemotherapy, patients
in both arms who are estrogen receptor positive may receive oral tamoxifen. Within 4
weeks after completion of chemotherapy and surgery, eligible patients in both arms also
undergo radiotherapy to the breast and lymph nodes.

Patients are followed at 30 and 90 days.

PROJECTED ACCRUAL: A total of 280-312 patients (140-156 per treatment arm) will be accrued
for this study.