August 14, 2013 - A new clinical study will evaluate preoperative focused microwave heat treatment and chemotherapy combined in the treatment of large breast cancer tumors in the intact breast.
In the randomized Phase III study, sponsored by Medifocus, researchers will evaluate 238 patients with locally advanced breast cancer and their response to treatment combining heat with chemotherapy before surgery. Principal investigator John R. Keyserlingk, MD, MSC, FRCS, FACS, Surgical Oncologist and Director of the VM Breast and Oncology Centers, will lead a multi-disciplinary team in combining preoperative microwave thermotherapy and chemotherapy to the breast to reduce the tumor burden beyond what can be provided by chemotherapy alone. The objective is to potentially shrink the tumor so that it can be removed in a breast conserving surgery (lumpectomy), thus reducing the need of a mastectomy.
Medifocus has initiated its Principal Investigational Site in Canada for its APA-1000 Focused Microwave Breast Thermotherapy System Pivotal Phase III clinical study. Dr. Keyserlingk will run the study at the VM Medical Center in Montreal, Canada, the largest non-public private breast center in Canada.
“When all, or nearly all, the tumor cells have been eliminated by the time the patient undergoes surgery, she then benefits from both best survival prognosis, and a reduced need for total mastectomy, the latter usually required for patients with large breast tumors. Upon successful completion of the study, and if approved, this technology will offer our patients, and many other breast cancer patients, additional and greatly needed treatment options, including potentially reducing the size of the surgical interventions," said Dr. Keyserlingk.
The Pivotal Phase III Breast Cancer treatment study has been approved to be initiated by both the USA Food and Drug Administration and the Canadian Bureau of Medical Devices (BMD). The USA Principal Investigational site has already been initiated at the University of Oklahoma Breast Institute under the supervision of the Company's U.S. Principal Investigator, Dr. William C. Dooley, MD.
For more information: www.medifocusinc.com,Back To Top