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According to a recent article published in the

Journal of Clinical Oncology, a novel agent tesmilifene (DPPE, BMS-217380-01) in addition to doxorubicin (Adriamycin®) improves survival compared to doxorubicin alone in the treatment of advanced breast cancer.

Breast cancer is diagnosed in over 200,000 women annually in the United States alone. Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body, often invading vital organs. Recurrent breast cancer refers to cancer that has progressed or returned following prior therapy. Depending upon the location and extent of cancer spread, patients with metastatic or recurrent breast cancer are often treated with the aim of extending the duration of survival and/or improving quality of life. Chemotherapy is a component of standard treatment for advanced breast cancer, with the chemotherapy agent doxorubicin being one of the most active agents in the treatment of breast cancer. Researchers continue to evaluate novel agents to improve outcomes for patients with advanced breast cancer.

Tesmilifene is an agent that has just completed the last phase of clinical trials prior to FDA review. Tesmilifene is used as an agent to enhance the effects of doxorubicin through a few mechanisms. Researchers speculate that tesmilifene enhances the anti-cancer effects of doxorubicin by decreasing a cancer cell’s ability to become resistant to chemotherapy, decreasing the metabolism or “breaking-down” of doxorubicin, and disrupting a cancer cell’s energy source.

A multi-center clinical trial was recently conducted to directly compare tesmilifene plus doxorubicin to doxorubicin alone in the treatment of advanced breast cancer. This trial included 305 patients, approximately half of whom were treated with tesmilifene plus doxorubicin and the other half of whom were treated with doxorubicin alone. Approximately 20 months following treatment, there were no significant differences in anti-cancer response rates, progression-free survival, or the average duration of response. However, overall survival was significantly improved in the group of patients treated with tesmilifene/doxorubicin (23.6 months), compared to those treated with doxorubicin alone (15.6 months). Patients treated with tesmilifene/doxorubicin experienced more nausea, vomiting, dizziness, hallucinations, movement disorders and loss of coordination than those treated with doxorubicin alone.

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The researchers concluded that the addition of tesmilifene to doxorubicin appears to improve survival over doxorubicin alone in the treatment of metastatic or recurrent breast cancer. Patients with advanced breast cancer may wish to speak with their physician about the risks and benefits of participating in a clinical trial further evaluating tesmilifene or other promising therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( and Personalized clinical trial searches are also performed on behalf of patients by

Reference: Reyno L, Seymour L, Tu D, et al. Phase III Study of N,N-Diethyl-2-[4-(Phenylmethyl) Phenoxy]Ethanamine (BMS-217380-01) Combined With Doxorubicin Versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer: National Cancer Institute of Canada Clinical Trials Group Study MA.19.

Journal of Clinical Oncology. 2004; 22:269-276.

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