Area women sought for cancer study

February 28, 2000|By JULIE E. GREENE

National researchers are looking for Tri-State area women to help them determine how effective an experimental drug is at preventing breast cancer.

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"Most women want to participate because they not only want to prevent breast cancer in themselves, but they want to have a role in preventing it in their daughters," said Jennifer Bucholtz, program coordinator with the Johns Hopkins Breast Center.

The study began last July and approximately 3,800 women have enrolled, but a total of 22,000 women are needed, Bucholtz said.

The John R. Marsh Cancer Center at the Robinwood Medical Center campus will begin taking calls today from possible volunteers as one of more than 500 sites in the United States, Canada and Puerto Rico for the study.


Women interested in participating in the study can call the Marsh Cancer Center at 301-665-4650 between 8 a.m. and 4 p.m. and say they are calling about the STAR Trial, for the Study of Tamoxifen and Raloxifene, said Patty Hanson, administrative director with the Marsh Cancer Center.

Researchers want to determine if the drug raloxifene is as effective as the drug tamoxifen when it comes to reducing breast cancer in high-risk women, Bucholtz said.

Tamoxifen has been proven to reduce the risk of breast cancer by 49 percent in high-risk women and is approved by the Food and Drug Administration for that purpose, Bucholtz said.

In rare instances, or 1 percent of women, tamoxifen can cause uterine cancer, Bucholtz said.

Raloxifene is a comparable drug, but researchers don't know the risks of uterine cancer from raloxifene in women with a high risk for breast cancer, according to study information.

Raloxifene was approved by the FDA to help prevent osteoporosis, the thinning of the bones, but is experimental when it comes to breast cancer prevention, according to study information.

Participants would take two pills once a day for five years, one of which would be either tamoxifen or raloxifene.

"They will get an active drug," Bucholtz said.

The other pill is a placebo or a fake. The placebo is needed because the two drugs come in differently shaped pills and researchers don't want participants or their doctors to know which active drug the participant is taking, Bucholtz said.

The most common side effects are hot flashes and vaginal drainage, she said.

Participants won't be paid, but can save approximately $120 a month in drug costs by volunteering, she said. The drugs are being provided for free by the drug companies, Astra Zeneca for tamoxifen and Eli Lilly for raloxifene.

Participants must be post-menopausal and at an increased risk to get breast cancer.

To determine an applicant's probable risk of getting breast cancer within five years, the applicant fills out a risk assessment form. Researchers use the Gail model, a proven risk prediction tool for breast cancer, to determine the applicant's risk level and explain the results.

Women who are at an increased risk to get breast cancer:

- Are of increasing age.

- Have a family history of breast cancer, especially in their mother, sister or daughter.

- Have a history of personal breast problems, especially biopsies.

- Started menstruating before 12 years old.

- Had children when more than 30 years old or have no children.

Eligible women cannot:

- Have uncontrolled hypertension.

- Have uncontrolled diabetes.

- Have atrial fibrillation, a rapid heartbeat.

- Have a history of blood clots.

- Have had breast cancer.

- Be taking blood thinner medications.

- Be taking hormones at the time of the study.

- Have had any type of cancer in the last five years.

Bucholtz encourages women to call and talk to the program's registered nurse if they have any questions concerning eligibility or the study.

If applicants are found to be initially eligible, based on the risk factors, they will meet with registered nurse Deborah Smith to go over their medical history and a consent form.

Participants wouldn't have to get more exams than they normally would and would see their regular doctors for the study. Since the exams required for the study are standard, such as mammograms and pelvic exams, the applicant's health insurance should cover those costs, Bucholtz said.

Researchers hope to have 22,000 participants enrolled within five years, so the study is expected to be done in about 10 years.

The study is being done by the National Surgical Adjuvant Breast & Bowel Project (NSABP) and the National Cancer Institute.

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