NCT01204801 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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)

Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in Female Patients With Intact Breast

Details for clinical trial NCT01204801

Clinical trial NCT01204801 - References