Statement of Norman Wolmark, MD
NSABP Chairman and Principal Investigator
The National Surgical Adjuvant Breast and Bowel Project (NSABP) is greatly disappointed in the National Cancer Instituteís (NCI) decision not to fund the Study to Evaluate Letrozole and Raloxifene (STELLAR), or P-4. This study was designed to help us identify the risks and benefits of alternative therapies to help high-risk women make more informed choices in their fight against breast cancer. We believe that letrozole has the potential to prevent the incidence of breast cancer by up to 70 percent, which could greatly enhance current options for these women.
NSABP and our trial centers maintain our belief in the scientific integrity and validity of the P-4 study, and the importance of such long-term trials to the advancement of science. We appreciate the endorsement of the seven NCI committees that approved this trial prior to NCI Director Niederhuberís decision to cancel funding. We also appreciate the thousands of women who wrote letters supporting this trial and are saddened by the fact that the infrastructure of more than 500 trial centers we have built up over the last 15 years will cease to exist due to the cancellation of this trial.
NSABP is concerned that the debate resulting from the NCIís cancellation of funding, and the resulting discussions about the potential side effects of letrozole (which is currently used to treat breast cancer) and raloxifene (which is currently used to prevent and treat osteoporosis), may cause some women to discontinue their treatment with these medications. It is imperative that women understand that these drugs are both approved by the Food and Drug Administration and help hundreds of thousands of women each year. While all drugs have side effects that need to be considered, women should not discontinue current therapies without talking with their doctors about the relative benefits and liabilities of the medication.
The NSABPís heritage is in cancer treatment and prevention. We will continue to pursue our goal of reducing the burden of this disease on our society and want to thank the more than 33,000 healthy women who have helped us do just that by participating in past prevention trials.
Background of NSABP Breast Cancer Prevention P-4 Study
Clinical research studies offer us the best hope for the proper evaluation of drugs and medical techniques.
This site offers you the opportunity to obtain credible information on clinical trial research and to assess your chances
of getting breast cancer.
Many drugs, agents, and remedies have been suggested to prevent cancer. This Web site
supports and advocates only those that have undergone the rigorous testing of
a U.S. federally approved clinical trial that are
sponsored by the National Cancer Institute (NCI).
Two such clinical trials include the Breast Cancer Prevention Trial (BCPT) and the Study of Tamoxifen
and Raloxifene (STAR). The BCPT included more than 13,000 women at increased risk for breast cancer and demonstrated the value of the drug
tamoxifen in reducing the incidence of the disease in this population. The second prevention trial, STAR, is one of the largest breast cancer
prevention studies ever untaken. This study recruited more than 19,000 volunteers and closed to enrollment in October 2004. Preliminary results
of this trial are now available at www.nsabp.pitt.edu.
This Web site is a product of the
National Surgical Adjuvant Breast and Bowel