Hunterdon Regional Cancer Center Recruiting Participants For Breast Cancer Prevention Study

Chances are someone you know has been diagnosed with breast cancer. In fact, according to the American Cancer Society, one in eight women will get breast cancer during her lifetime and 183,000 American women will be diagnosed with breast cancer this year.

Now, women may be able to do something to reduce their risk of developing breast cancer. The Hunterdon Regional Cancer Center (HRCC), through its affiliation with Fox Chase Cancer Center in Philadelphia, is offering postmenopausal women the opportunity to enroll in the second national breast cancer prevention study. Nicknamed "STAR", for the Study of Tamoxifen and Raloxifene, the study will compare the effects of those two drugs in reducing the occurrence of breast cancer in postmenopausal women who are at increased risk of the disease.

"Risk factors for breast cancer include a strong family history of breast cancer, older age, breast lumps requiring biopsy, early onset of menstruation, not having borne children or having a first child after age 30," said oncologist Kenneth Blankstein, principal research investigator for the HRCC.

STAR is sponsored by the National Surgical Adjuvant Breast and Bowel Project. STAR's primary focus will be to determine the following:

• The effectiveness of raloxifene (as compared to tamoxifen) in reducing the risk of invasive breast cancer in postmenopausal women;
• if either drug helps reduce heart disease, since both drugs have been shown to lower levels of the cholesterol associated with heart disease;
• the comparative rates of other benefits and side effects.

Tamoxifen, marketed as Nolvadex by AstraZeneca Pharmaceuticals, is the most widely prescribed cancer drug in the world. It has been used for nearly 25 years in the treatment of cancer patients with advanced breast cancer. Since 1985, the drug has also been used as an adjuvant or follow-up therapy after radiation and/or surgery for early-stage breast cancer to prevent recurrence.

Tamoxifen has been proven to reduce the rate of invasive breast cancer by 49% among women at high risk of the disease. In addition, the published report on tamoxifen shows that the drug reduces the incidence of non-invasive breast cancers by 50%. Consequently, the Food and Drug Administration (FDA) has approved the use of tamoxifen as the first drug to reduce the risk of breast cancer in healthy women at risk of developing the disease.

"Women at high risk of breast cancer now have a very effective drug, tamoxifen, to help lower the risk of developing the disease," said Dr. Blankstein. "Raloxifene, however, may be able to offer a safer and equally effective prevention drug that could also prove to have other life-saving benefits."

Raloxifene, marketed as Evista by Eli Lilly and Company, has been approved in the United States and several other countries for use in the prevention of osteoporosis. Clinical trials designed to study raloxifene's effect on osteoporosis revealed that women taking the drug had a lower rate of breast cancer than a control group not taking the drug.

Both drugs are selective estrogen receptor modulators (SERMS), which act like estrogen in some ways but not in others. SERMS appear to block the effects of estrogen that may promote breast cancer, while also providing the benefits of preventing osteoporosis.

Half the women in the STAR study will receive tamoxifen; the other half will receive raloxifene. The trial is double-blinded, meaning that neither the doctor nor the patient will know which drug is being administered until conclusion of the study. The HRCC has been participating in the STAR trial since 1999. They are actively recruiting additional women to enroll.

For more information on the study or to discuss enrollment, call Jackie Allen, CNS, AOCN, Prevention Research Nurse, at (908) 237-2330.