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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036998
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: thermal ablation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (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
Study Start Date : August 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036998

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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
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Study Chair: William E. Gannon, MD Celsion
Layout table for additonal information Identifier: NCT00036998    
Other Study ID Numbers: CDR0000069347
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: July 2004
Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases