Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced 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: NCT00036985
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 : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

May 13, 2002
January 27, 2003
December 19, 2013
August 2001
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Complete list of historical versions of study NCT00036985 on Archive Site
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Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.


  • 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.

Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Procedure: thermal ablation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Chair: William E. Gannon, MD Celsion
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP