BATTLING BREAST CANCER: NATIONWIDE STUDY FOCUSES ON PREVENTION

The statistics are grim.

An estimated 175,000 new cases of breast cancer are expected to be diagnosed in the United States this year. In Missouri alone, some 900 new cases will be diagnosed.

Nationwide, breast cancer is expected to kill about 43,700 women this year.

Around the world, 1 million women a year develop breast cancer. Annually, over 400,000 die from the disease.

Nancy Mattingly knows the statistics. So does Trinka Hileman.

Mattingly coordinates the cancer program at Southeast Missouri Hospital. Hileman is a registered nurse with St. Francis Medical Center's Womancare program.

Both women are helping to enroll volunteers in a new, nationwide breast cancer study.

Both Cape Girardeau hospitals are participating in the study of the drugs tamoxifen and raloxifene or STAR as the project is called.

They are among 400 STAR sites in the United States, Puerto Rico and Canada.

Nationwide, some 22,000 women are being sought to participate in the study.

To be eligible, women must have an increased risk of developing breast cancer, be at least 35 years old and have gone through menopause.

Participants must have an increased risk of breast cancer equal to or greater than that of an average 60- to 64-year-old woman. At that age, about 17 of every 1,000 women are expected to develop breast cancer.

STAR is limited to post-menopausal women because the drug raloxifene has yet to be adequately tested for long-term safety in pre-menopausal women, medical experts say.

Women who have been diagnosed with breast cancer aren't eligible.

Two local cancer doctors -- Stanley D. Sides and Benjamin H. Yuen -- are involved in the study.

Sides, Yuen and the two Cape Girardeau hospitals are part of the National Surgical Adjuvant Breast and Bowel Project, a network of research professionals that will conduct the STAR study.

The five-year study, scheduled to begin later this month, is designed to determine whether the osteoporosis prevention drug raloxifene is as effective in reducing the chance of developing breast cancer as tamoxifen has been.

Tamoxifen was shown to reduce the chance of developing breast cancer by about half in a nationwide study of over 13,000 pre-menopausal and postmenopausal women. St. Francis and Southeast also participated in that trial. The two hospitals saw about 17 women as part of that study.

Mattingly and Hileman hope for more participants this time.

In the first study, half of the participants nationwide received a placebo.

This time, all the participants will receive an anti-cancer drug, either tamoxifen or raloxifene. Hileman said that might encourage more area women to participate in the study.

While tamoxifen helped reduce the risk of breast cancer in some women, the previous study found there was an increased risk of developing cancer in the lining of the uterus.

The new study will look at raloxifene to see if it might be a safer and better drug in the battle to prevent breast cancer, Sides said.

Raloxifene was approved in December 1997 by the Federal Drug Administration as a medicine for the prevention of osteoporosis. The drug has been used in clinical trials for about five years.

Tamoxifen has been FDA-approved for the treatment of breast cancer for more than 20 years and has been in clinical trials for about 30 years, medical experts say.

Sides such much of the cancer research in the world takes place in the United States.

"In a real sense, people need to understand we do much of this for the world," he said.

The latest study and other studies could provide a wealth of data that could help prevent breast cancer, said Sides.

Women who volunteer for the study will be asked to fill out a risk assessment form. The forms will be sent to the breast project organization, based out of the University of Pittsburgh.

"They determine if the women are qualified," said Mattingly.

Those who qualify will be randomly assigned to receive either tamoxifen or raloxifene pills. They will be required to take the pills daily for five years and will have regular follow-up exams, including mammograms and gynecologic exams.

For the first year, the women will have to visit their assigned hospitals every three months. After that, the visits will be reduced to every six months.

The participants must fill out periodic questionnaires. "We will do blood tests and give them their next supply of pills," said Mattingly.

The women won't know which drug they are taking, she said.

Zeneca Pharmaceuticals, which manufactures tamoxifen, and Eli Lilly, which makes raloxifene, are providing the drugs for the study free of charge.

Eli Lilly also provided a $36 million grant to defray recruitment costs and help local investigators conduct the study.

Mattingly said the hospitals are reimbursed for some expenses associated with the study. But they don't begin to break even.

The hospitals participate to help further the treatment of breast cancer.

Sides said he and Yuen don't get paid for their participation in the study either.

Sides said it is the women with a high risk of breast cancer who benefit from such studies.

St. Francis' Hileman said such studies are important to the long-term treatment of breast cancer. "If we don't have a study, we can't effectively market these drugs."

Hileman, who will help collect data for the study, said she already has had 15 women express an interest in participating in the study.

"Some women are open about it and others I think are scared of a study," she said.

Mattingly said those who have a high risk of getting breast cancer should consider volunteering for the study. "They have something to gain," she said.

How to participate in the STAR study?

Persons interested in participating in the breast cancer study should contact Southeast Missouri Hospital's Regional Cancer Center or St. Francis Medical Center's Physician Resource Center.

To reach Southeast, call (573) 651-5550 or 1-800-455-4636.

To contact St. Francis, call (573) 331-5111 or 1-888-254-2778.

Who can participate?

Women with an increased risk of developing breast cancer, who have gone through menopause and are at least 35 years old.