drugset / Trial / NCT01204801
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Background Vargas HI; Dooley WC; Fenn AJ; Tomaselli MB; and Harness JK. Study of preoperative focused microwave phased array thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for large breast carcinomas. Cancer Therapy. 2007;5B:401-408. Available; http://www.cancer-therapy.org/CT5B/pdf/45._Vargas_et_al,_401-408.pdf. Accessed November 25, 2007. (background for protocol)
- Background Dooley WC, Vargas HI, Fenn AJ, Tomaselli MB, Harness JK. Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: a review of clinical studies. Ann Surg Oncol. 2010 Apr;17(4):1076-93. doi: 10.1245/s10434-009-0872-z. Epub 2009 Dec 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Background | Epirubicin | Small molecule | 100 mg/m2 | — |