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Randomized Controlled Trial
. 2010 Jun;3(6):696-706.
doi: 10.1158/1940-6207.CAPR-10-0076. Epub 2010 Apr 19.

Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer

Victor G Vogel  1 , Joseph P Costantino, D Lawrence Wickerham, Walter M Cronin, Reena S Cecchini, James N Atkins, Therese B Bevers, Louis Fehrenbacher, Eduardo R Pajon, James L Wade 3rd, André Robidoux, Richard G Margolese, Joan James, Carolyn D Runowicz, Patricia A Ganz, Steven E Reis, Worta McCaskill-Stevens, Leslie G Ford, V Craig Jordan, Norman Wolmark; National Surgical Adjuvant Breast and Bowel Project
Affiliations
Randomized Controlled Trial

Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer

Victor G Vogel et al. Cancer Prev Res (Phila). 2010 Jun.

Abstract

The selective estrogen-receptor modulator (SERM) tamoxifen became the first U.S. Food and Drug Administration (FDA)-approved agent for reducing breast cancer risk but did not gain wide acceptance for prevention, largely because it increased endometrial cancer and thromboembolic events. The FDA approved the SERM raloxifene for breast cancer risk reduction following its demonstrated effectiveness in preventing invasive breast cancer in the Study of Tamoxifen and Raloxifene (STAR). Raloxifene caused less toxicity (versus tamoxifen), including reduced thromboembolic events and endometrial cancer. In this report, we present an updated analysis with an 81-month median follow-up. STAR women were randomly assigned to receive either tamoxifen (20 mg/d) or raloxifene (60 mg/d) for 5 years. The risk ratio (RR; raloxifene:tamoxifen) for invasive breast cancer was 1.24 (95% confidence interval [CI], 1.05-1.47) and for noninvasive disease, 1.22 (95% CI, 0.95-1.59). Compared with initial results, the RRs widened for invasive and narrowed for noninvasive breast cancer. Toxicity RRs (raloxifene:tamoxifen) were 0.55 (95% CI, 0.36-0.83; P = 0.003) for endometrial cancer (this difference was not significant in the initial results), 0.19 (95% CI, 0.12-0.29) for uterine hyperplasia, and 0.75 (95% CI, 0.60-0.93) for thromboembolic events. There were no significant mortality differences. Long-term raloxifene retained 76% of the effectiveness of tamoxifen in preventing invasive disease and grew closer over time to tamoxifen in preventing noninvasive disease, with far less toxicity (e.g., highly significantly less endometrial cancer). These results have important public health implications and clarify that both raloxifene and tamoxifen are good preventive choices for postmenopausal women with elevated risk for breast cancer.

Trial registration: ClinicalTrials.gov NCT00003906.

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Figures

Fig. 1
Fig. 1
Cumulative incidence of invasive and noninvasive breast cancer.
Fig. 2
Fig. 2
Cumulative incidence of invasive uterine cancer and thromboembolic events.
See this image and copyright information in PMC

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