BETHESDA, MdIn 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 womans
risk include a family history of breast cancer, personal medical
history, age at first menstrual period, and age at first live birth.
STAR researchers are attempting to recruit a significant number of
minority women into the trial. An analysis done at the NCIs
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 NCIs 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
Women in the placebo arm of the BCPT trial were given the option of
joining STAR, and 1,126 of them enrolled in the trials first
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).