To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Clinical Trial Aimed at Improving Treatment for Breast Cancer URL: http://www.pslgroup.com/dg/9552.htm Doctor's Guide June 6, 1996
TORONTO, June 6, 1996 -- Improving treatment for women with breast cancer is the focus of a new clinical trial announced jointly today by the National Cancer Institute of Canada and Sandoz Canada Inc.. The trial will be looking at post-operative adjuvant (supplementary) treatment of breast cancer. Approximately 800 Canadian women will be recruited to the trial, which is scheduled to begin in summer 1996. In a randomized fashion, the women will receive either the drug tamoxifen by itself, or a combination of tamoxifen and an agent called octreotide. The women will be followed for seven years to ascertain if there is improved survival and quality of life for the women taking the combination of the two drugs. The clinical trial of the octreotide-tamoxifen combination has come about as a result of successful laboratory research conducted by Dr. Michael Pollak and colleagues. Pollak is also the principal investigator for the clinical trial, which will be run at approximately 45 centres across Canada. Adjuvant treatment with tamoxifen has been shown in clinical trials to prolong disease-free survival in many women with early breast cancer. Nevertheless, relapse of breast cancer despite adjuvant therapy remains a problem. "This points out the urgent clinical need to develop improved adjuvant therapies,'' says Pollak at the National Cancer Institute of Canada's (NCIC) Science Writers' Symposium in Toronto today. Pollak's laboratory research showed that in a rat breast cancer model, 50 per cent of animals treated with tamoxifen were disease-free after 18 weeks follow-up, while 90 percent of animals treated with the tamoxifen-octreotide combination were disease-free at 18 weeks. "This research is very exciting,'' says Pollak, Associate Director of Medicine and Oncology, McGill University, Montreal. "The idea of combining an anti-estrogen such as tamoxifen with a somatostatin analogue such as octreotide was based on our earlier basic research concerning factors that regulate breast cancer cell growth. While all basic research that increases understanding of cancer is useful, only a small percentage of laboratory work suggests a new therapeutic approach that is appropriate for immediate evaluation in a clinical trial.'' Pollak adds that while laboratory findings can suggest new cancer therapies only clinical trials can determine if a new therapeutic approach is truly a step forward. This is why the NCIC Clinical Trials Group hopes to complete the octreotide-tamoxifen trial in the shortest time possible. In addition to the main goal of determining if the new treatment results in improved outcome for women with breast cancer, blood and tumour specimens obtained from participating patients will help scientists obtain new leads for further research. "The strategy of using laboratory results to guide clinical trials and then using clinical results and specimens to re-direct laboratory research is useful in accelerating progress in cancer research,'' says Pollak. Sandoz Canada Inc.., manufacturers of octreotide, is investing more than $4 million to this research program, which is one of the company's largest investments in Canadian research. The NCIC is supporting the trial through its Clinical Trials Group, based in Kingston, Ontario, which will administer the project. "For fifty years now, the National Cancer lnstitute of Canada has supported laboratory research because many answers about cancer have been, and continue to be, uncovered through this type of research,'' says Dr. Robert Phillips, President, NCIC. "It is rewarding to see basic research pay off with promising clinical trials. This trial is a good example of one of these payoffs.'' "Sandoz recognizes that Canada is an excellent place to invest in research and development because of the high calibre of the Canadian research community,'' says Dr. Jean-Paul Castaigne, Corporate Vice-President, Medical and Regulatory Affairs, Sandoz. "In recent years Sandoz has tripled its funding of research and development in Canada. The company is committed to researching and developing effective and novel treatments in the oncology field as shown by this protocol as well as by other ongoing ones involving GLI328 to treat brain tumours and PSC833 for multi-drug resistance in cancer therapy. We are pleased to be working with the NCIC on this new clinical trial, which has the potential to help people with breast cancer across Canada.'' If women are interested in participating in the "Clinical Trial of the Octreotide/Tamoxifen Combination'' they can contact Susan Marlin at NCIC Clinical Trials Group (1-613-545-6430) for more information. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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