Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-Year results from the MORE trial

J. A. Cauley, L. Norton, M. E. Lippman, S. Eckert, K. A. Krueger, D. W. Purdie, J. Farrerons, A. Karasik, D. Mellstrom, K. W. Ng, J. J. Stepan, T. J. Powles, M. Morrow, A. Costa, S. L. Silfen, E. L. Walls, H. Schmitt, D. B. Muchmore, V. C. Jordan

Research output: Contribution to journalArticle

Abstract

Raloxifene, a selective estrogen receptor modulator approved for the prevention and treatment of postmenopausal osteoporosis, has shown a significant reduction in breast cancer incidence after 3 years in this placebo-controlled, randomized clinical trial in postmenopausal women with osteoporosis. This article includes results from an additional annual mammogram at 4 years and represents 3,004 additional patient-years of follow-up in this trial. Breast cancers were ascertained through annual screening mammograms and adjudicated by an independent oncology review board. A total of 7,705 women were enrolled in the 4-year trial: 2,576 received placebo, 2,557 raloxifene 60 mg/day, and 2,572 raloxifene 120 mg/day. Women were a mean of 66.5-years old at trial entry, 19 years postmenopause, and osteoporotic (low bone mineral density and/or prevalent vertebral fractures). As of 1 November 1999, 61 invasive breast cancers had been reported and were confirmed by the adjudication board, resulting in a 72% risk reduction with raloxifene (relative risk (RR) 0.28, 95% confidence interval (CI) 0.17, 0.46). These data indicate that 93 osteoporotic women would need to be treated with raloxifene for 4 years to prevent one case of invasive breast cancer, Raloxifene reduced the risk of estrogen receptor-positive invasive breast cancer by 84% (RR 0.16, 95% CI 0.09, 0.30). Raloxifene was generally safe and well-tolerated, however, thromboembolic disease occurred more frequently with raloxifene compared with placebo (p = 0.003). We conclude that raloxifene continues to reduce the risk of breast cancer in women with osteoporosis after 4 years of treatment, through prevention of new cancers or suppression of subclinical tumors, or both. Additional randomized clinical trials continue to evaluate this effect in postmenopausal women with osteoporosis, at risk for cardiovascular disease, and at high risk for breast cancer.

Original languageEnglish
Pages (from-to)125-134
Number of pages10
JournalBreast Cancer Research and Treatment
Volume65
Issue number2
DOIs
Publication statusPublished - 2001

Fingerprint

Risk Reduction Behavior
Breast Neoplasms
Osteoporosis
Placebos
Randomized Controlled Trials
Confidence Intervals
Postmenopause
Selective Estrogen Receptor Modulators
Raloxifene Hydrochloride
Postmenopausal Osteoporosis
Estrogen Receptors
Bone Density
Neoplasms
Cardiovascular Diseases
Incidence
Therapeutics

Keywords

  • Breast cancer
  • Menopause
  • MORE trial
  • Osteoporosis
  • Raloxifene
  • SERM
  • STAR trial
  • Tamoxifen

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Cauley, J. A., Norton, L., Lippman, M. E., Eckert, S., Krueger, K. A., Purdie, D. W., ... Jordan, V. C. (2001). Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-Year results from the MORE trial. Breast Cancer Research and Treatment, 65(2), 125-134. https://doi.org/10.1023/A:1006478317173

Continued breast cancer risk reduction in postmenopausal women treated with raloxifene : 4-Year results from the MORE trial. / Cauley, J. A.; Norton, L.; Lippman, M. E.; Eckert, S.; Krueger, K. A.; Purdie, D. W.; Farrerons, J.; Karasik, A.; Mellstrom, D.; Ng, K. W.; Stepan, J. J.; Powles, T. J.; Morrow, M.; Costa, A.; Silfen, S. L.; Walls, E. L.; Schmitt, H.; Muchmore, D. B.; Jordan, V. C.

In: Breast Cancer Research and Treatment, Vol. 65, No. 2, 2001, p. 125-134.

Research output: Contribution to journalArticle

Cauley, JA, Norton, L, Lippman, ME, Eckert, S, Krueger, KA, Purdie, DW, Farrerons, J, Karasik, A, Mellstrom, D, Ng, KW, Stepan, JJ, Powles, TJ, Morrow, M, Costa, A, Silfen, SL, Walls, EL, Schmitt, H, Muchmore, DB & Jordan, VC 2001, 'Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-Year results from the MORE trial', Breast Cancer Research and Treatment, vol. 65, no. 2, pp. 125-134. https://doi.org/10.1023/A:1006478317173
Cauley, J. A. ; Norton, L. ; Lippman, M. E. ; Eckert, S. ; Krueger, K. A. ; Purdie, D. W. ; Farrerons, J. ; Karasik, A. ; Mellstrom, D. ; Ng, K. W. ; Stepan, J. J. ; Powles, T. J. ; Morrow, M. ; Costa, A. ; Silfen, S. L. ; Walls, E. L. ; Schmitt, H. ; Muchmore, D. B. ; Jordan, V. C. / Continued breast cancer risk reduction in postmenopausal women treated with raloxifene : 4-Year results from the MORE trial. In: Breast Cancer Research and Treatment. 2001 ; Vol. 65, No. 2. pp. 125-134.
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