October 20, 2000

Enrollment high in breast cancer trial

Featured Image

Albert Reynolds, Ph.D., left, and Panos Anastasiadis’, Ph.D., research is featured on the cover of September’s issue of Nature Cell Biology. (photo by Dana Johnson)

Enrollment high in breast cancer trial

Enrollment at the Vanderbilt-Ingram Cancer Center in one of the largest-ever breast cancer prevention trials exceeded expectations in the study’s first year, with four more years of accrual to go.

Since the study opened at Vanderbilt-Ingram last October, nearly 35 women have enrolled in the Study of Tamoxifen and Raloxifene. Vanderbilt-Ingram is the only center in middle Tennessee and southern and western Kentucky to participate in STAR. Vanderbilt-Ingram coordinators have now doubled their annual enrollment projection from 20 to 40 participants.

At the more than 400 STAR sites in the United States, Canada and Puerto Rico, over 6,000 women volunteered during the first year, it was announced recently. Investigators aim to recruit an additional 16,000 women over the next four years.

Based on results of an earlier Breast Cancer Prevention Trial, tamoxifen has been approved to reduce the incidence of breast cancer among women at high risk for the disease. Raloxifene is an osteoporosis drug that has shown some potential for also reducing the risk of breast cancer.

“This head-to-head comparison is essential to determine whether raloxifene works as well as or better than tamoxifen and, importantly, whether one is safer than the other,” said Dr. Mark Kelley, a surgical oncologist leading Vanderbilt-Ingram’s contribution tothe trial.

STAR is sponsored by the National Surgical Adjuvant Breast and Bowel Project and supported by the National Cancer Institute. The NSABP and the NCI announced that more than 47,000 women went through the individualized, no-obligation risk assessment to determine their risk of breast cancer and weigh the pros and cons of joining the trial, during the first year of enrollment.

Many did not have an increased risk of breast cancer and were therefore ineligible; however, 29,303 were eligible. Of those, 6,139 made the decision, based on personal reasons and their overall health, to volunteer, the NCI and NSABP said in a statement.

Women may be eligible to participate in STAR if they are post menopausal, at least 35 years old, and have an increased risk of breast cancer as determined by a number of factors, including age, family history of breast cancer, and personal medical history.

Tamoxifen and raloxifene appear to work similarly against breast cancer, a disease that affects 180,000 women each year in the United States and which causes more than 40,000 deaths. They both work to block the effects of estrogen, a hormone which can promote the abnormal cell growth associated with cancer.

Side effects of both drugs include menopausal symptoms such as hot flashes. Both may increase the risk of rare but potentially life-threatening blood clots in a large vein or in the lung, and tamoxifen use may also increase risk of stroke and endometrial cancer at a rate comparable to hormone replacement therapy.

Women of all races are encouraged to participate in the trial, which is supported by the National Medical Association, a network of more than 20,000 African-American physicians. Recent analyses of tamoxifen in women with breast cancer show that the drug works equally well in white and black women, the NCI and NSABP said.

After an eligible woman decides to participate, she is randomly assigned to receive daily doses of tamoxifen or raloxifene for five years. Regular follow-up examinations include mammograms and gynecological exams.

AstraZeneca Pharmaceuticals and Eli Lilly and Company, which make tamoxifen and raloxifene respectively, are providing the drugs for the trial free of charge. Eli Lilly has also awarded NSABP a $36 million, five-year grant to defray recruitment costs at participating centers.

For more information about STAR

•The Vanderbilt-Ingram Cancer Center Information Program, 1-800-811-8480.

•”STAR Trial: An Overview,” a free information session, Tuesday, Oct. 24, 7 p.m., Cool Springs YMCA, 121 Seabord Ln., Brentwood.

•The NCI Information Program, 1-800-4-CANCER