Upstate News

May 25, 1999
Kathleen Paice 315 464-4839

Hematology-Oncology Associates of Central New York, University Hospital to Participate in Major Breast Care Prevention Trial

Hematology-Oncology Associates of Central New York and University Hospital in Syracuse will begin recruiting volunteers for one of the largest breast cancer prevention studies ever – the Study of Tamoxifen and Raloxifene (STAR).

Serving as principal investigators for STAR in Central New York are Seema A. Khan, M.D., of University Hospital at the State University of New York Health Science Center, and Jeffrey J. Kirshner, M.D., of the Syracuse Community Clinical Oncology Program at Hematology-Oncology Associates of Central New York.

“The Study of Tamoxifen and Raloxifene will enable the medical community and the public to gain a greater understanding of risks and benefits of these two drugs,” said Dr. Khan, director of research at University Hospital’s Breast Care Center and author of a key 1997 study on the link between estrogen levels and breast cancer.

Dr. Kirshner, who headed the first breast cancer prevention study in Syracuse, added, “Women everywhere are at risk for breast cancer, and we are pleased that Central New York women will have the chance to participate in this important study.”

Hematology-Oncology Associates of Central New York and University Hospital in Syracuse are part of the Surgical Adjuvant Breast and Bowel Project (NSABP), the network of research professionals that will conduct STAR, which is supported by the National Cancer Institute.

The national trial will include 22,000 postmenopausal women at increased risk of breast cancer to determine whether osteoporosis prevention drug raloxifene (Evista) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex) has proven to be.

Women who participate in STAR must be:

  • postmenopausal;
  • at least 35 years old;
  • and have an increased risk of breast cancer, determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth.

Interested women 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 of tamoxifen or 60 mg raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.

Tamoxifen was shown to reduce the chance of developing breast cancer by about half in the breast Cancer Prevention Trial (BCPT), a study of over 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 September 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 slightly 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. 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 in October 1998.

Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis and has been in clinical trials for about five years. In those studies, women who received raloxifene as opposed to a placebo were found to have a lower incidence of breast cancer. Whether this drug can actually prevent breast cancer in high risk women remains to be deterrmined. 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 was not shown to increase the risk of developing 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.

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 participating centers to help local investigators conduct the study.

For information on participating in STAR call: Kathleen Shedlock, RNNP at Hematology-Oncology Associates of Central New York at (315)-472-7504, or University Hospital Health Connections at 315-464-8668.

More information can be obtained online by visiting the NSABP’s website or the NCI clinical trial site.

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