For Immediate Release
July 15, 2008

Roswell Park Study Focuses on Premenopausal Women at High Risk for Breast Cancer

BUFFALO, NY – Premenopausal women with high risk of breast cancer are invited to participate in a chemoprevention study to determine if whole flaxseed has the potential to reduce their risk for the disease. Swati Kulkarni, MD, Department of Surgery, Roswell Park Cancer Institute (RPCI), is the principal investigator.

Flaxseed is a commonly available food often consumed as a dietary supplement and is a rich source of lignans, a phytoestrogen. Lignans have been shown to reduce tumor growth and metastasis in laboratory models and reduce markers of cell growth in human tumors. Flaxseed is safe and has no known serious side effects.

Tamoxifen is the only drug approved by the U.S. Food and Drug Administration for chemoprevention of breast cancer in premenopausal women. However, tamoxifen has a number of side effects, including hot flashes, irregular menstruation and increased risk for endometrial cancer. For this reason, many healthy women choose not to take tamoxifen, while others are ineligible for this drug treatment due to their medical histories. As a result, the vast majority of premenopausal women who are at significant risk of developing breast cancer are not taking any risk-reducing agents.

The pilot study at Roswell Park, sponsored by the National Cancer Institute, will enroll 50 premenopausal women to help determine if flaxseed has the potential to be a successful chemopreventive agent in breast cancer. At the beginning and end of the study, women will undergo a Random Breast Fine Needle Aspiration to obtain random samples of breast cells for evaluation. Some women will be asked to consume 25 grams of ground flaxseed daily, with meals, for six months. Some participants will be monitored throughout the study. All will be evaluated for changes in biomarkers in breast cells and through proteins found in their blood.

“Approximately 70% of women at high risk for breast cancer decide to forego tamoxifen therapy, due to the drug’s unfavorable side effects. Flaxseed may offer an attractive alternative to these women,” said Dr. Kulkarni. “It is our hope that data from this research will lead to a larger randomized study comparing flaxseed to tamoxifen.”

For more information about the study, call 1-877-ASK-RPCI (1-877-275-7724).

Roswell Park Cancer Institute, founded in 1898, is the nation’s first cancer research, treatment and education center. The Institute was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. RPCI is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

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