The Effect of Raloxifene on Risk of Breast Cancer in Postmenopausal Women: Results From the MORE Randomized Trial
Abstract
CONTEXT: Raloxifene hydrochloride is a selective estrogen receptor modulator that has antiestrogenic effects on breast and endometrial tissue and estrogenic effects on bone, lipid metabolism, and blood clotting. OBJECTIVE: To determine whether women taking raloxifene have a lower risk of invasive breast cancer. DESIGN AND SETTING: The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double-blind trial, in which women taking raloxifene or placebo were followed up for a median of 40 months (SD, 3 years), from 1994 through 1998, at 180 clinical centers composed of community settings and medical practices in 25 countries, mainly in the United States and Europe. PARTICIPANTS: A total of 7705 postmenopausal women, younger than 81 (mean age, 66.5) years, with osteoporosis, defined by the presence of vertebral fractures or a femoral neck or spine T-score of at least 2.5 SDs below the mean for young healthy women. Almost all participants (96%) were white. Women who had a history of breast cancer or who were taking estrogen were excluded. INTERVENTION: Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60 mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets. MAIN OUTCOME MEASURES: New cases of breast cancer, confirmed by histopathology. Transvaginal ultrasonography was used to assess the endometrial effects of raloxifene in 1781 women. Deep vein thrombosis or pulmonary embolism were determined by chart review. RESULTS: Thirteen cases of breast cancer were confirmed among the 5129 women assigned to raloxifene vs 27 among the 2576 women assigned to placebo (relative risk [RR], 0.24; 95% confidence interval [CI], 0.13-0.44; P<.001). To prevent 1 case of breast cancer, 126 women would need to be treated. Raloxifene decreased the risk of estrogen receptor-positive breast cancer by 90% (RR, 0.10; 95% CI, 0.04-0.24), but not estrogen receptor-negative invasive breast cancer (RR, 0.88; 95% CI, 0.26-3.0). Raloxifene increased the risk of venous thromboembolic disease (RR, 3.1; 95% CI, 1.5-6.2), but did not increase the risk of endometrial cancer (RR, 0.8; 95% CI, 0.2-2.7). CONCLUSION: Among postmenopausal women with osteoporosis, the risk of invasive breast cancer was decreased by 76% during 3 years of treatment with raloxifene.
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Administration of the antiestrogen raloxifene for only 3 yr in postmenopausal women led to a 76% decrease in the incidence of breast cancer.
“administration of the antiestrogen raloxifene for only 3 yr in postmenopausal women led to a 76% decrease in the incidence of breast cancer (82)”
From Endocrine and intracrine sources of androgens in women: inhibition of breast cancer and other roles of androgens and their precursor dehydroepiandrosterone (2003) · cites this paper as [82]
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- Authors
- Cummings, S. R., Eckert, S., Krueger, K. A., Grady, D., Powles, T. J., Cauley, J. A., Norton, L., Nickelsen, T., Bjarnason, N. H., Morrow, M., Lippman, M. E., Black, D., Glusman, J. E., Costa, A., & Jordan, V. C.
- Affiliations
- University of California, San Francisco (US)
- Eli Lilly (United States) (US)
- Northwestern University (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1999-06-16
- Volume
- 281
- Issue
- 23
- Pages
- 2189
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2172185687
- Cited by
- 1,872
- References
- 46
- Citations by year
- 2026: 12 · 2025: 22 · 2024: 24 · 2023: 20 · 2022: 18 · 2021: 25 · 2020: 24 · 2019: 33 · 2018: 25 · 2017: 29 · 2016: 21 · 2015: 46 · 2014: 47 · 2013: 54 · 2012: 59
- FWCI
- 121.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › 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, estrogen receptor-positive breast cancer, endometrial hyperplasia, endometrial cancer, venous thromboembolism, drug safety and efficacy, risk-benefit assessment, tamoxifen comparison
- MeSH terms
- Aged, Breast Neoplasms, Double-Blind Method, Estrogen Antagonists, Estrogens, Female, Follow-Up Studies, Humans, Piperidines, Receptors, Estrogen, Risk, Thromboembolism, Osteoporosis, Postmenopausal, Endometrial Neoplasms, Postmenopause, Raloxifene Hydrochloride
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