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Continued Breast Cancer Risk Reduction in Postmenopausal Women Treated with Raloxifene: 4-Year Results from the MORE Trial
Open accessAbstract
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 compa…
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Raloxifene is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
“Raloxifene is also indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [83–86].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [83]
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Metadata
- Authors
- 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.
- Affiliations
- University of Pittsburgh (US)
- Memorial Sloan Kettering Cancer Center (US)
- Georgetown University (US)
- Eli Lilly (United States) (US)
- University of Hull (GB)
- Sheba Medical Center (IL)
- The University of Melbourne (AU)
- Charles University (CZ)
- Royal Marsden NHS Foundation Trust (GB)
- Northwestern University (US)
- European Institute of Oncology (IT)
- ORCID
- Venue
- Breast Cancer Research and Treatment
- Published
- 2001-01
- Volume
- 65
- Issue
- 2
- Pages
- 125-134
- ISSN
- 0167-6806 (ISSN-L)
- 1573-7217
- OpenAlex
- W1986364825
- Cited by
- 678
- References
- 28
- Citations by year
- 2026: 1 · 2025: 11 · 2024: 5 · 2023: 7 · 2022: 11 · 2021: 8 · 2020: 15 · 2019: 13 · 2018: 12 · 2017: 16 · 2016: 16 · 2015: 22 · 2014: 21 · 2013: 21 · 2012: 20
- FWCI
- 46.50
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- Breast Cancer Research and Treatment (publishedVersion)
- PubMed (publishedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Estrogen and related hormone effects
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- raloxifene, selective estrogen receptor modulators, breast cancer prevention, postmenopausal women, osteoporosis, MORE trial, estrogen receptor-positive breast cancer, thromboembolic events, long-term follow-up
- MeSH terms
- Aged, Aged, 80 and over, Australia, Breast Neoplasms, Double-Blind Method, Estrogen Antagonists, Europe, Female, Follow-Up Studies, Humans, Mammography, Middle Aged, New Zealand, Risk Factors, United States, Osteoporosis, Postmenopausal, Incidence, Ultrasonography, Mammary, Postmenopause, Selective Estrogen Receptor Modulators, Raloxifene Hydrochloride
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