The STAR Trial: Evidence for Raloxifene as a Breast Cancer Risk Reduction Agent for Postmenopausal Women

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  • 1 From the University of Texas M. D. Anderson Cancer Center, Houston, Texas.

The 1998 approval of tamoxifen for breast cancer risk reduction opened the era of breast cancer chemoprevention. Women at increased risk for breast cancer now had an option other than healthy lifestyle and prophylactic surgery to reduce risk. However, women and their physicians were reluctant to use tamoxifen because of associated risks. Several trials investigating raloxifene suggested it may reduce breast cancer risk without having an apparent effect on the endometrium. The Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer trial opened in 1999 to directly compare raloxifene to tamoxifen for breast cancer risk reduction. Since the unblinding of the STAR trial in 2006, raloxifene has emerged as an option for reducing breast cancer risk for postmenopausal women at increased risk for the disease.

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Correspondence: Therese B. Bevers, MD, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1322, Houston, TX 77030. E-mail: tbevers@mdanderson.org
  • 1.

    Jordan VC. Selective estrogen receptor modulation: a personal perspective. Cancer Res 2001;61:56835687.

  • 2.

    Lamb CA, Helguero LA, Fabris V. Differential effects of raloxifene, tamoxifen and fulvestrant on a murine mammary carcinoma. Breast Cancer Res Treat 2003;79:2535.

    • Search Google Scholar
    • Export Citation
  • 3.

    Sporn MB, Dowsett SA, Mershon J, Bryant HU. Role of raloxifene in breast cancer prevention in postmenopausal women: clinical evidence and potential mechanisms of action. Clin Ther 2004;26:830840.

    • Search Google Scholar
    • Export Citation
  • 4.

    Ettinger B, Black DM, Mitlak BH. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) investigators. JAMA 1999;282:637645. Erratum in JAMA 1999;282:2124.

    • Search Google Scholar
    • Export Citation
  • 5.

    Cummings SR, Eckert S, Krueger KA. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. JAMA 1999;281:21892197. Erratum in JAMA 1999;282:2124.

    • Search Google Scholar
    • Export Citation
  • 6.

    Cauley JA, Norton L, Lippman ME. Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial. Multiple Outcomes of Raloxifene Evaluation. Breast Cancer Res Treat 2001;65:125134. Erratum in Breast Cancer Res Treat 2001;67:191.

    • Search Google Scholar
    • Export Citation
  • 7.

    Martino S, Cauley JA, Barrett-Connor E. Continuing Outcomes Relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst 2004;96:17511761.

    • Search Google Scholar
    • Export Citation
  • 8.

    Barrett-Connor E, Mosca L, Collins P. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006;355:125137.

    • Search Google Scholar
    • Export Citation
  • 9.

    Delmas PD, Bjarnason NH, Mitlak BH. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 1997;337:16411647.

    • Search Google Scholar
    • Export Citation
  • 10.

    Vogel VG, Costantino JP, Wickerham DL. The study of tamoxifen and raloxifene: preliminary enrollment data from a randomized breast cancer risk reduction trial. Clin Breast Cancer 2002;3:153159.

    • Search Google Scholar
    • Export Citation
  • 11.

    Vogel VG, Costantino JP, Wickerham DL, Cronin WM. National Surgical Adjuvant Breast and Bowel Project update: prevention trials and endocrine therapy of ductal carcinoma in situ. Clin Cancer Res 2003;9(1 Pt 2):495S501S.

    • Search Google Scholar
    • Export Citation
  • 12.

    Vogel VG, Costantino JP, Wickerham DL. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 2006;295:27272741. Erratum in JAMA 2006;296:2926.

    • Search Google Scholar
    • Export Citation
  • 13.

    Gail MH, Brinton LA, Byar DP. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 1989;81:18791886.

    • Search Google Scholar
    • Export Citation
  • 14.

    Land SR, Wickerham DL, Costantino JP. Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 2006;295:27422751.

    • Search Google Scholar
    • Export Citation
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