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Worldwide Research Group To Compare Breast Cancer Treatments
COLLEGEVILLE, Pa., March 4, 1997 -- A new, worldwide collaboration has been formed to compare the efficacy of various treatments for breast cancer. Created by and the Alberta Cancer Board and Rhone-Poulenc Rorer Inc. (NYSE: RPR) (RPR), the International Taxotere Breast Study Group is slated to begin in April 1997.
The five-year program will investigate Taxotere-based chemotherapy combinations. The studies are designed to measure survival and disease-free survival in women with early-stage breast cancer, and could lead to a new standard in breast cancer treatment. The collaboration is headed by Dr. Jean-Marc Nabholtz of the Cross Cancer Institute in Edmonton, Alberta, Canada.
The Research Program
Expected to involve 1,600 women with breast cancer, the trial will enroll patients from Europe, the U.S., Canada, South America and other countries. The program will consist of two adjuvant-therapy studies, the first comparing Taxotere(R) (docetaxel) in combination with Adriamycin(R) (doxorubicin) and cyclophosphamide (TAC) with one of the most common initial treatments, a combination of 5-fluorouracil (5-FU), Adriamycin and cyclophosphamide (FAC). The second study will evaluate whether the Taxotere combination is made more effective by adding high-dose chemotherapy and peripheral stem-cell transplantation. Women in these studies will undergo treatment with one combination or the other according to randomized protocols.
Taxotere was cleared for marketing in the United States in May 1996, and, worldwide, has received marketing clearance in 49 countries to date. In the U.S., Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer whose disease has progressed during anthracycline-based therapy or who have relapsed during anthracycline-based adjuvant therapy.
In patients with normal liver function, side effects reported to date include neutropenia, thrombocytopenia, anemia, fluid retention, hypersensitivity, nausea and diarrhea. A premedication regimen with corticosteroids is recommended to prevent or reduce the severity of fluid retention and hypersensitivity. Taxotere is not appropriate therapy for some patients with liver impairment. The program developed by the International Taxotere Breast Study Group will focus on the study of Taxotere as first-line therapy. "We can now study Taxotere in a setting where we can investigate its potential to save lives," said Dr. Nabholtz.
Taxotere was developed and is marketed worldwide by Rhone-Poulenc Rorer Inc.
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