* While tamoxifen has been shown to reduce, by half, the incidence of lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS), raloxifene did not have an effect on these diagnoses. (LCIS and DCIS are sometimes called noninvasive breast cancers.) Of the 9,726 women taking tamoxifen, 57 developed LCIS or DCIS, compared to 81 of 9,745 taking raloxifene. This result confirms data reported in 2004 in a large study of raloxifene, the Continued Outcomes Relevant to Evista (or CORE Trial).

Women who participated in STAR were postmenopausal, at least 35 years old, and had an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. Before participating in the study, the women were instructed about the potential risks and benefits of tamoxifen and raloxifene and then were asked to sign an informed consent document.


STAR investigators will present additional data at the 42nd annual meeting of the American Society for Clinical Oncology (ASCO) from June 2-6, 2006, in Atlanta, Ga. "This is an important and long awaited trial," said Sandra J. Horning, M.D., president of ASCO, "and we look forward to further discussion and analysis at the ASCO annual meeting that will address the observed differences in toxicity and prevention of non-invasive breast cancers with the two treatment approaches." A manuscript is also being submitted to a peer-reviewed journal for publication.

The maker of tamoxifen, AstraZeneca Pharmaceuticals, Wilmington, Del., and the maker of raloxifene, Eli Lilly and Company, Indianapolis, Ind., provided their drugs and matching placebos for the trial without charge to participants. Eli Lilly and Company also gave NSABP support to defray recruitment costs at the participating centers and to help local investigators conduct the study.

For more information about STAR, including links to media materials and a fact sheet, visit NCI's STAR home page at http://www.cancer.gov/star or NSABP's Web site at http://www.nsabp.pitt.edu or http://foundation.nsabp.org.

For a Q&A related to the STAR results, go to: http://www.cancer.gov/newscenter/pressreleases/STARresultsQandA.

For tools used to calculate a woman's risk of breast cancer, visit http://cancer.gov/bcrisktool or http://breastcancerprevention.com.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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