April 17, 2006
Unveiling of STAR trial results brings kudos to participants
Monday's announcement of the results of the five-year Study of Tamoxifen and Raloxifene (STAR) – which compared the drugs' ability to prevent breast cancer in postmenopausal women at risk for the disease – came with an expression of thanks to the 19,747 women in the U.S. and Canada who took part in the trial, including 226 at eight New England hospitals and healthcare systems headed by Dana-Farber.
The finding that the osteoporosis drug raloxifene works as well as tamoxifen in reducing breast cancer occurrence among postmenopausal women at increased risk for the disease, and with fewer side effects, has been hailed as an important step in breast cancer prevention. (Official results of the study are available at http://www.nci.nih.gov/star.) It reaffirms the role that patients can play in advancing progress against cancer, says Judy Garber, MD, MPH, director of the Friends of Dana-Farber Risk and Prevention Clinic, who led the Institute's involvement in the study.
"People who participate in cancer-prevention trials contribute something vital," Garber remarks. "Many of the women in the STAR trial will never directly benefit from its findings; they enrolled for the sake of the generations of women who come after them."
The study's success also reflects on the work of staff at more than 500 participating hospitals and health centers, Garber continued. Each site is required by the study's organizer, the National Surgical Adjuvant Breast and Bowel Project, to have a designated principal investigator, project coordinator and pharmacist, and to follow detailed guidelines for obtaining patient consent and collecting data.
Jennifer Thibodeau, a clinical research coordinator who worked with Dana-Farber's 48 study participants, says the experience has sparked an appreciation of the human dimension of science. "It's been very inspiring to work with these women," she says. "It's been wonderful to see their commitment to women's health in general and to taking a proactive stance toward their own health."
One way to help
For many participants, the study offered a means, however modest, to carry forward the fight against cancer, says Suzanne Blanchard of Duxbury, who decided to join the trial when her 37-year-old daughter, Bambi, developed inflammatory breast cancer in 1998. "You feel so helpless as a parent when your child has something like this. There's a sense of despair: you want to fight this disease in any way possible, but you don't know what to do," she says. "I felt the STAR trial offered a way of being proactive."
Significant as the STAR will be, it is hardly the last word in breast cancer prevention studies, Garber notes. Several studies are under way, or soon will be, to find even better alternatives to tamoxifen or raloxifene. Prominent among these drugs is a class of compounds known as aromatase inhibitors, which reduce estrogen production and are already in use in the treatment of postmenopausal women with hormone-sensitive breast cancers.
"From STAR and other studies we know that medications like tamoxifen and raloxifene are remarkably effective in reducing breast cancer risk, but, like all medications, they do have side effects," Garber said. "The next set of studies will explore whether other medications are even more effective and produce fewer or different side effects."
Beyond that, much more work is needed to develop and test preventive medications for women at risk for breast cancer not fueled by estrogen – so-called ER-negative tumors, she continues.
"The climate of breast cancer prevention is undergoing a change, in part as a response to studies like STAR," she says. "We hope people will begin to think of breast cancer prevention in the same way that they think of taking a statin drug to prevent heart disease. This study is a big step forward."
Study of Tamoxifen and Raloxifene (STAR) Trial
View breast and ovarian cancer risk and prevention research studies
