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| |  NSABP To Begin New Trial of Taxotere(r) (docetaxel) For Breast Cancer COLLEGEVILLE, Pa., Jan. 18, 1996 -- Rhone-Poulenc Rorer Inc.(NYSE: RPR) and the National Surgical Adjuvant Breast and Bowel Project (NSABP) announced today the initiation of a new clinical trial utilizing Taxotere(R) (docetaxel), a new anticancer agent. The primary goal of the study is to determine if Taxotere can improve disease-free survival time and survival time of women with operable breast cancer. "It is our goal by using Taxotere in the pre-operative setting to further improve the results of prior NSABP studies," said Dr. Norman Wolmark, NSABP Chairman. These prior studies have shown that 80% of breast cancers shrink with conventional chemotherapy and more patients have the option to undergo lumpectomy. The NSABP investigators will study the effects of Taxotere in women with operable breast cancer who are receiving standard treatments with Adriamycin(R) (doxorubicin hydrochloride), cyclophosphamide and Tamoxifen. "After a review of new agents to treat breast cancer, Taxotere was chosen by NSABP, since it has shown remarkable response rates as a single agent in women with advanced breast cancer," said Dr. Mamounas, Assistant Director Medical Affairs, NSABP and Protocol Officer for the study. "RPR is proud that Taxotere has been chosen for what is sure to be a landmark oncology treatment study," said Dr. Robert Bellet, Associate Director of Oncology, RPR. "It's in the best interest of cancer patients that numerous large scale trials like this one are conducted to enhance our knowledge and improve patient outcome. Beyond this study, RPR is committed to an extensive clinical trial program of our own for Taxotere." A total of 1,500 women are expected to be enrolled in 250 NSABP investigator sites in the U.S. and Canada. Women eligible for the trial must have operable breast cancer diagnosed by fine-needle aspiration (FNA) cytology or by core needle biopsy. Women will be randomized into one of three groups. The first group will receive a current standard regimen which is four cycles of Adriamycin(R) and cyclophosphamide plus tamoxifen (ACT) for five years. Following completion of chemotherapy, surgery will be performed to remove the local tumor. The second group will receive ACT followed by four cycles of Taxotere. Then, surgery will be performed as in Group I. The third group will receive ACT, followed by surgery and four cycles of Taxotere given post-operatively. For further information on this trial and other studies underway with Taxotere, patients and health care professionals can call a toll- free clinical trial hotline, 1-800 RX TRIAL (1-800-798-7425). Callers will receive information on study participation requirements and be directed, if appropriate, to a local site. If a patient is not eligible for a Taxotere clinical trial, they will be directed to another cancer hotline, such as 1-800-4-CANCER for more information. Taxotere belongs to a unique class of anticancer agents called taxoids that have been found to inhibit cancer cell division by acting on the cell's internal skeleton which is made up of elements called microtubules. Microtubules assemble and disassemble during the cell cycle. Taxotere promotes the assembly and blocks the disassembly of microtubules, thus preventing cancer cells from dividing. This action can lead to cancer cell death. The National Surgical Adjuvant Breast and Bowel Project is a large clinical trials group headquartered in Pittsburgh. Rhone-Poulenc Rorer Inc.. is a global pharmaceutical company dedicated to improving human health. Note: Adriamycin(R) is a registered trademark of Pharmacia, Inc.
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