STAR Enrollment Tops 6,000 in First Year of Recruitment

BETHESDA, Md—In its first year, the Study of Tamoxifen and Raloxifene (STAR) enrolled 6,139 of the 22,000 postmenopausal women it hopes to recruit. “Six thousand in, 16,000 to go,” the National Cancer Institute (NCI) said in a press release.

The trial seeks to determine if raloxifene (Evista) is as effective as tamoxifen (Nolvadex) in reducing breast cancer in women who are at high risk of developing the disease.

More than 47,000 women have gone through a risk assessment for the study, and of these, 29,303 were eligible for the trial on the basis of their breast cancer risk. The majority of them chose not to participate. Nonetheless, research leaders expressed satisfaction with the number of women who did enter the trial during year 1.

STAR evolved from two previous studies. The 13,000-woman Breast Cancer Prevention Trial (BCPT) showed that tamoxifen reduced the chances of developing breast cancer in high-risk women. The drug was later approved by the Food and Drug Administration to reduce the risk of breast cancer.

Raloxifene is approved for the prevention and treatment of osteoporosis. In a large osteoporosis study known as MORE, the drug also reduced the incidence of breast cancer.

The trial is being conducted by the National Surgical Breast and Bowel Project and supported by the NCI. To be eligible, a woman must be at least 35 years old, postmenopausal, and have the breast cancer risk of a 60-year-old female, which is a 1.7% chance of developing the disease over 5 years.

“The women who are actually choosing to join the trial, as a group, exceed that minimum requirement,” NCI said.

Risk factors other than age that are used to calculate a woman’s risk include a family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth.

Minority Enrollment

STAR researchers are attempting to recruit a significant number of minority women into the trial. An analysis done at the NCI’s Division of Cancer Prevention revealed that tamoxifen is equally effectively in black and white women.

“The benefits and risks of tamoxifen are the same in African-American and white women,” said NCI’s Worta McCaskill-Stevens, MD, who reported the findings at the 36th Annual Meeting of the American Society of Clinical Oncology. “Women of all races can feel comfortable about considering STAR if they are at increased risk of breast cancer.”

During the first year, 6,636 minority women went through the risk-assessment process, 1,812 were found eligible for the trial on the basis of their breast cancer risk, and 281 decided to join it.

Among all the women who have enrolled in STAR to date, 103 (1.7%) are black; 81 are Hispanic (1.3%), and 97 (l.6%) are from other minorities.

Women in the placebo arm of the BCPT trial were given the option of joining STAR, and 1,126 of them enrolled in the trial’s first year.

Information on participating in STAR is available for those in the United States and Puerto Rico by calling 1-800-422-6237 (United States and Puerto Rico), or 1-888-939-3333 (Canada).