The Community Hospital Announces Participation in Major Breast Cancer Prevention Trial

The Community Hospital in Munster, Ind. is the only site in Northwest Indiana and one of more than 400 in the United States, Canada and Puerto Rico that will enroll women in one of the largest breast cancer prevention studies ever.

The Study of Tamoxifen and Raloxifene, or STAR, will involve 22,000 postmenopausal women at increased risk of breast cancer. The intent of the study is to determine whether the osteoporosis prevention drug raloxifene (Evista®) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex®) has proved to be.

"We're very excited about bringing this important study to the communities of Northwest Indiana and South Suburban Chicago," said Edward P. Robinson, Administrator of The Community Hospital. "Our participation in this study reflects our deep commitment to ensure that residents of our communities have access to the most advanced cancer care."

The Community Hospital is part of the National Surgical Adjuvant Breast and Bowel Project, the network of research professionals that will conduct STAR, which is supported by the National Cancer Institute (NCI). Medical Oncologist Dr. Erwin Robin will serve as Community Hospital's principal investigator in the project, which will be done through an affiliation with Rush-Presbyterian-St. Luke's Medical Center in Chicago.

"With this study, we will help further the landmark work that has already been done to find a way to prevent breast cancer," Dr. Robin said. "In this next step, we hope to expand our knowledge of how to prevent breast cancer with the fewest side effects possible."

The Community Hospital is expected to begin enrolling volunteers in July to participate in the STAR study. Interested volunteers may call the Star Coordinator at 219-836-6391 for more information or access our web site at www.communityhospital.org.

Tamoxifen was shown to reduce the chance of developing breast cancer by about half in the Breast Cancer Prevention Trial (BCPT), a study of more than 13,000 premenopausal and postmenopausal women at high risk of breast cancer.

Results of this trial were announced a year ago (April 6, 1998) and published in the Journal of the National Cancer Institute on Sept. 16, 1998. In the BCPT, half the women took tamoxifen and half took a placebo (an inactive pill that looked like tamoxifen). Participants taking tamoxifen also had fewer fractures of the hip, wrist and spine than women taking the placebo.

However, the drug increased the women's chances of developing four potentially life-threatening health problems: endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in large veins), pulmonary embolism (blood clot in the lung) and possibly stroke.

In October 1998, The U.S. Food and Drug Administration (FDA) approved the use of tamoxifen to reduce the incidence of breast cancer in women at increased risk of the disease.

Leslie Ford, M.D., associate director for clinical research in NCI's Division of Cancer Prevention, noted that "tamoxifen is a medically proven intervention, but it is not perfect. Women who are at an increased risk of breast cancer need options for preventing this disease with a minimum of side effects, and STAR is a concerted effort to find one." Ford is responsible for all aspects of NCI's involvement in STAR.

Information about the safety of raloxifene is limited compared to the data available on tamoxifen. Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis and has been in clinical trails for about five years. Tamoxifen has been approved by the FDA to treat women with breast cancer for more than 20 years and has been in clinical trials for about 30 years.

Women taking raloxifene in studies of osteoporosis have had an increased chance of developing a deep vein thrombosis or pulmonary embolism similar to the risk seen with tamoxifen. In these studies, raloxifene did not increase the risk of endometrial cancer. An important part of STAR will be to compare the long-term safety of raloxifene and tamoxifen in women at increased risk for breast cancer.

Women who participate in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. All of these factors are assessed through the National Breast Cancer Institute's Breast Risk Assessment, a computerized test the Community Hospital piloted this past year.

Beginning July 1, all women who have a mammogram at the hospital's Women's Diagnostic Center, will be given the opportunity -- at no charge -- to complete this breast risk assessment, which can determine the risk of developing breast cancer within the next five years and within the woman's lifetime (age 90). The use of this new tool will help identify women who might be at increased risk and would be candidates for tamoxifen or who may wish to participate in the STAR study.

All women who wish to participate in the STAR study will go through a process known as informed consent, during which they will learn about the potential benefits and risks of tamoxifen and raloxifene before deciding whether to participate in STAR.

Once a woman chooses to participate, she will be randomly assigned to receive either 20 mg tamoxifene, or 60 mg raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.

The maker of tamoxifen, Zeneca Pharmaceuticals, Wilmington, Del., and the maker of raloxifene, Eli Lilly and Company, Indianapolis, Ind., are providing their drugs for the trial without charge. Eli Lilly and Company has also given NSABP a $36 million grant to defray recruitment costs at the participating centers and to help local investigators conduct the study.

More information about STAR and a list of participating centers:

In the United States (including Puerto Rico), call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for information in English or Spanish. The number for callers with TTY equipment is 1-800-332-8615.

In Canada, call the Canadian Cancer Society at 1-888-939-3333 for information in English or French.

Visit NSABP's Web site at www.nsabp.pitt.edu or NCI's clinical trials Web site at cancertrials.nci.nih.gov