BMS 217380 01, DOXORUBICIN AND TAXOL FOR BREAST CANCER

$0M01FY2000RRNIH

New York University School Of Medicine, New York NY

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Abstract

Approximately 1 in 8 women will develop breast cancer in her lifetime. It is the most common cancer in women and the second leading cause of cancer deaths in women. Therapy of metastatic breast cancer is at present not that successful. This study attempts to add BMS-217380-01 (DPPE) to the current first line therapy (doxorubicin and taxol) of patients with advanced breast cancer. BMS-217380-01 (DPPE), a novel antihistaminic compound, appears to act as an adjuvant for standard chemotherapeutic agents. It inhibits cellular proliferation of malignant cells by an unknown mechanism. The primary objectives of this open label study are to determine the objective tumor response rate of BMS-217380-01 (DPPE) plus doxorubicin in combination with taxol when administered as first line treatment to patients with metastatic or locally advance breast cancer. The secondary objectives are to determine the safety, response rate and duration of response in the patients administered this regimen.

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