Six months into a national study to see whether the cancer drug tamoxifen is useful in preventing breast cancer in women age 35 and older, it appears that young women with breast cancer in their immediate family are the most motivated to participate in the five-year study.
Some 16 women already have been placed on the study at Eastern Maine Medical Center — the only Maine hospital chosen to participate, and 10 of those are ages 35-49. Five are in their 50s, and only one woman is over 60.
The statistics are not far from what’s happening nationally in the study, according to Dr. Philip Brooks, who is running EMMC’s portion of the study at the Clinic for Cancer and Blood Disorders with Drs. C. Eric Hartz, Thomas Openshaw and Harvey Segal, and physician’s assistant Dennis Chinoy.
The 120 primary centers around North America have placed 1,654 in the study so far, about one-tenth as many as can be accommodated. Some 705 of those women are ages 35-49, 463 are in their 50s, and 486 are over 60.
One of the risk factors for breast cancer is the presence of the disease in a first-degree relative — one’s mother, sister or daughter — and Brooks believes that that is the reason for the high interest in the study among women in the younger category.
This kind of information is being compiled not only locally, but through information gathered from data managers at all the primary centers. Margaret Fowler, who compiles the data in the clinic at EMMC, recently attended a meeting of all the data managers in Pittsburgh. Sponsors of the trial are the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project.
The Breast Cancer Prevention Trial involves healthy women who are chosen for the study on the basis of risk factors such as family history, age, or a history of benign biopsies. Among all women in the United States, it is estimated that one in eight will be diagnosed with breast cancer in her lifetime.
Half the women in the “double-blind” study will take tamoxifen — the most widely used cancer drug in the world — and the other half will take placebos. Until the study is over, neither the women nor their physicians will know who is taking what.
The 50-50 distribution does not necessarily mean that eight of the 16 women at EMMC are taking tamoxifen. The selection of which patients get the tamoxifen is “randomized” nationally, Brooks said, so the numbers of women taking the drug locally could be higher or lower.
The choice of tamoxifen as the drug to use in this study was certainly not by chance. The drug, which has been used for years, decreases the chances that cancer will spread, and makes it less likely that breast cancer will recur in a woman who has had it already.
The women in this study have not had breast cancer, but are at a greater risk for it than the general population. They may accrue other benefits as well, Brooks pointed out, such as reduced chances of cardiac disease and osteoporosis. Like estrogen, the hormone produced by the ovaries before menopause, tamoxifen has been found to lower cholesterol, and also to decrease bone thinning in older women.
After the initial announcement of the study the end of April, some 278 women contacted the EMMC clinic to indicate their interest in participation. Some did not return the questionnaire needed to apply for the study, Brooks said, and some said they did not want to participate because they were concerned about possible side effects. “We’re being very rigorous with the informed-consent process,” he said.
A few woman declined on the advice of their physicians, Brooks said, although “the physicians have been, by and large, very cooperative.”
Other women who were taking estrogen after normal menopause or hysterectomy were not willing to stop taking the estrogen, a requirement since tamoxifen has some of the same effects on the body. Trading estrogen for tamoxifen is not a given, since some of the women would be taking placebos.
Several women are nearly ready to join the program, Brooks said, but are waiting for final lab results or to have their yearly mammogram. A mammogram within the past six months is required.
Even if all the women going through the process do join the study, there will be room for more. Initial plans had called for EMMC to take up to 150 women in the five-year study, which requires being seen three months after the initial workup, then every six months.
Since the Bangor hospital is the only primary center in the state, Brooks is hopeful of taking on patients from a wide area. Women from as far away as Portland and Eastport have joined the study, he said.
Those who complete the questionnaire do gain something from the process, he pointed out. The clinic gives them an assessment of their risk for breast cancer, which can be helpful in other areas of their health care.
The drugs taken are provided free through the study, although there is some cost for checkups and tests. For those who do not have insurance, Brooks hopes fund raising or other means can be found to help pay.
He anticipates that many more women will take the opportunity to participate in the study, which may reduce their risk for breast cancer. He is particularly encouraged that the early participants are sticking with the program. “To our knowledge, all are doing fine and seem to be pleased,” he said.
For information on the Breast Cancer Prevention Trial, contact the Clinic for Cancer and Blood Disorders at EMMC at 945-7481.