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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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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


- 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

- 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.

Inclusion Criteria


- Histologically confirmed locally advanced primary breast cancer

- Stage III (T2-3, N2-3) disease

- Diagnosis not made by lumpectomy or incisional biopsy

- Currently a candidate for mastectomy and neoadjuvant chemotherapy

- Primary tumor measurable by breast ultrasound and clinical exam

- No bilateral breast cancer

- No high probability for extensive intraductal in situ disease

- No clinical fixation to the pectoralis major muscle or skin

- No involvement of the nipple

- No inflammatory breast cancer

- No multicentric disease

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 6 months


- Platelet count at least 100,000/mm^3 (no thrombocytopenia)

- No bleeding disorders


- PT and PTT less than 1.5 times normal

- INR less than 1.5 times normal

- Bilirubin no greater than 2.0 mg/dL

- Transaminases no greater than 2 times normal

- No coagulopathy

- No liver disease


- BUN less than 30 mg/dL OR

- Creatinine less than 1.9 mg/dL

- No renal insufficiency


- No clinically significant heart disease

- No pacemakers or defibrillators


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception

- No breast implants

- No prior collagen vascular disease

- No concurrent mental condition that would preclude study

- No contraindications to chemotherapy

- Able to tolerate prone position and breast compression


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics


- No prior participation in this study

- More than 30 days since participation in another clinical trial

- No concurrent participation in another clinical trial

- No concurrent anticoagulants

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

William E. Gannon, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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