Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Befo… (NCT01204801) | Clinical Trial Compass
UnknownPhase 3
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors
United States, Canada238 participantsStarted 2010-11
Plain-language summary
The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large breast cancer tumors in the intact breast. Combining heat with chemotherapy before surgery might shrink the tumor so that it can be removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female subject must be 18 years of age or older.
✓. Subject must have adequate cognitive function to understand and sign the IRB/EC - approved informed consent prior to the performance of any study-specific procedure.
✓. The subject must be at no risk for pregnancy either postmenopausal for at least one year, surgically sterile (i.e. hysterectomy), using two forms of birth control one being barrier method or practicing abstinence throughout the length of the study. The subject must also have a negative serum pregnancy test prior to any study-specific procedure.
✓. Subject must have diagnosis by core biopsy of primary breast cancer, invasive ductal carcinoma or invasive lobular carcinoma, clinical tumor size 3.5 cm or greater, tumor classification T2 or T3, clinically node positive (N1, N2) or node negative (N0) by clinical exam, CT scan, or ultrasound, with distant metastasis (M1) or without distant metastasis (M0), with an indication for mastectomy.
✓. Primary tumor must be measurable on breast ultrasound (US).
✓. Primary tumor must be measurable by clinical exam.
✓. Subject is a candidate for mastectomy and is eligible for neoadjuvant treatment.
✓. Subject is a candidate for preoperative anthracycline-based combination chemotherapy.
Exclusion criteria
✕. Pregnant or lactating subject.
✕. Mentally unable to participate in the study successfully because they are unable to understand the informed consent or unable to comply with the required study procedures.
What they're measuring
1
Tumor Shrinkage (ultrasound)
Timeframe: Prior to Surgery, on average 4 months from the start of treatment