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Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 13, 2002
Last updated: November 5, 2013
Last verified: July 2004

RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature.

PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.

Condition Intervention Phase
Breast Cancer
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: thermal ablation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Detailed Description:


  • 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.

  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary breast cancer by core needle biopsy

    • T1a, b, c, or T2
    • Diagnosis not made with a lumpectomy or incisional biopsy
  • Candidate for breast conservation surgery (lumpectomy/radiotherapy)
  • Tumor measurable by breast ultrasound
  • No metastatic disease, including skin metastases
  • No bilateral breast cancer
  • No high-probability of extensive intraductal disease in situ
  • 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, INR, and PTT 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
  • Creatinine less than 1.9 mg/dL
  • No renal insufficiency


  • No pacemakers or defibrillators
  • No clinically significant heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception, including 1 barrier method
  • Able to tolerate prone position and breast compression
  • No breast implants
  • No prior collagen vascular disease
  • No other factor or condition (other than tumor size) that would preclude lumpectomy
  • No mental condition that would preclude study


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics


  • No prior participation in this study
  • More than 30 days since prior participation in another clinical study
  • No concurrent anticoagulants
  Contacts and Locations
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Please refer to this study by its identifier: NCT00036998

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
United States, Florida
Comprehensive Breast Center of Coral Springs
Coral Springs, Florida, United States, 33071
United States, Oklahoma
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Mroz-Baier Breast Care Center
Memphis, Tennessee, United States, 38119
United States, Virginia
Breast Care Specialists, P.C.
Norfolk, Virginia, United States, 23510
United States, Washington
Tacoma, Washington, United States, 98405
United Kingdom
Royal Bolton Hospital
Bolton, Lancashire, England, United Kingdom, BL4 0JR
Sponsors and Collaborators
Study Chair: William E. Gannon, MD Celsion
  More Information Identifier: NCT00036998     History of Changes
Other Study ID Numbers: CDR0000069347
Study First Received: May 13, 2002
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 27, 2017