Women wanted for
breast cancer study

By Helen Altonn
Star-Bulletin

Eligible Hawaii women have an opportunity to participate in a major national study of two drugs -- tamoxifen and raloxifene -- with the potential to prevent breast cancer.

The University of Hawaii's Cancer Research Center is one of 400 centers conducting the study in the United States, Canada and Puerto Rico.

The five-year program, called STAR, is expected to involve 22,000 postmenopausal women, age 35 and older, with a high risk of breast cancer. The study is being conducted by the National Surgical Breast and Bowel Project, a network of cancer researchers, with National Cancer Institute backing.

The UH center hopes to get at least 50 participants and is aiming for 100, said Ann Kelminski, clinical research associate and project coordinator for the studies.

The goal is to enroll "as many women in the islands as we can who would want to be part of the study."

The Hawaii center participated in an earlier national tamoxifen trial that showed the drug decreased the risk of breast cancer by 49 percent and also resulted in fewer fractures of the hip, wrist and spine.

Based on the results, the U.S. Food and Drug Administration in October approved the drug for use in women with a high risk for breast cancer.

However, tamoxifen also increases the chances of four life-threatening health problems: cancer of the uterine lining, deep-vein thrombosis (blood clots in large veins), pulmonary embolism (blood clot in the lung), and possibly stroke.

Raloxifene was tested in clinical studies for osteoporosis at 40 sites, including Hawaii. The drug appeared to have advantages over tamoxifen -- protecting both the breast and uterus against cancer. But it had risks similar to tamoxifen for deep-vein thrombosis and pulmonary embolism.

STAR is an effort to find options to prevent the disease and keep side-effects to a minimum. The program will compare the drugs and their long-term safety.

"It's pretty exciting for us -- just seeing this as an offspring of the previous study," Kelminski said. "All the women who were part of that played such a big role in making this happen."

Interested participants must have increased risk of breast cancer as determined by age, medical history or other factors.

They will randomly receive either 20 milligrams of tamoxifen or 60 milligrams of raloxifene daily for five years. They will receive mammograms, gynecologic exams and regular follow-up examinations.

Zeneca Pharmaceuticals, which makes tamoxifen, and Eli Lilly and Co., which makes raloxifene, will provide free drugs for the trial. Eli Lilly also has provided $36 million to help with recruitment and investigation costs at the centers.

In 1997, 841 Hawaii women were diagnosed with invasive breast cancer, according to the Cancer Center. An estimated 175,000 American women will be diagnosed with the disease this year, with about 800 expected in Hawaii, the center said.

Probably because of earlier detection and treatment, the incidence of breast cancer has leveled off and the death rate declined, the center said. The great challenge now is prevention.

HOW TO JOIN TESTS Women interested in participating may call the clinical trials unit, 586-2979; the Cancer Information Service of Hawaii, 1-800-4-CANCER or 1-800-422-6237. Information also is available on the National Surgical Breast and Bowel Project Website at http://www.nsabp.pitt.edu, or the National Cancer Institute's Website at http://cancertrials.nci.nih.gov.