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University Daily Kansan / Thursday. April 30, 1992
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Tests begin for breast-cancer drug
BETHESDA, Md. — The National Cancer Institute yesterday launched the first large-scale test of a drug aimed at preventing breast cancer in women that are most at risk. The project will take five years and will study 16,000 women.
The Associated Press
The trial will be open to women over the age of 60, and to women aged 35 to 59 who demonstrate certain risk factors for breast cancer.
Researchers also want to find out if the drug, tamoxifen, is effective in preventing heart disease and osteoporosis, a condition in which bones become fragile.
Tamoxifen is the most widely prescribed cancer drug in the world, and for years it has been used in treating breast cancer, the institute said.
"its anti-tumor effects in humans have been demonstrated," said
Bernard Fisher, a physician and chief investigator for the clinical trial.
In addition, it appears that the drug may prevent heart disease by lowering cholesterol and could delay further progression of osteoporosis, Fisher said.
Side effects, however, include the risk of blood clots and uterine cancer in older women. There also have been studies indicating that massive doses cause liver tumors in rats.
Women in the test will not be able to take estrogen treatment or birth control pills because such combinations may cause cancer, the institute said.
Fisher said those side effects are rare and the possible benefits outweigh the risks.
But the institute plans to keep track of the women for the rest of their lives to see if any of these problems develop, he said.
"Forever is a long time, but that's what it is," Fisher said.
The trial will be conducted at 270 sites in the United States and Canada. Half of the women in the test will be given a 20-milligram daily dose of tamoxifen, the other half will take a placebo.
It is a "double blind" test, meaning that neither the women involved nor their physicians will know whether they are taking the real drug or the placebo.
Leslie Ford, chief of the institute's community oncology and rehabilitation branch, said the project is the first large-scale test of a drug to prevent cancer. Other tests of similar scale have been for cancer treatment.
Women with no symptoms and no other problems should not consider taking the drug as a means of avoiding breast cancer. Fisher said.
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