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Results From the MORE Randomized Trial

Steven R. Cummings, MD; Stephen Eckert, PhD; Kathryn A. Krueger, MD; Deborah Grady, MD; Trevor J. Powles, PhD; Jane A. Cauley, DrPH, FRCP; Larry Norton, MD; Thomas Nickelsen, MD, PhD; Nina H. Bjarnason, MD; Monica Morrow, MD; Marc E. Lippman, MD; Dennis Black, PhD; Joan E. Glusman, MD; Alberto Costa, MD; V. Craig Jordan, PhD, DSc

JAMA. 1999;281:2189-2197.

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.

Author Affiliations: Departments of Medicine (Dr Cummings) and Epidemiology and Biostatistics (Drs Cummings, Grady, and Black), University of California, San Francisco; Eli Lilly and Co, Indianapolis, Ind (Drs Eckert, Krueger, Nickelsen, and Glusman); Breast Unit, Royal Marsden NHS Trust Hospital, Sutton, England (Dr Powles); Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pa (Dr Cauley); Department of Breast Cancer Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY (Dr Norton); Center for Clinical and Basic Research, Ballerup, Denmark (Dr Bjarnason); Department of Surgery (Dr Morrow) and the Robert H. Lurie Cancer Center (Dr Jordan), Northwestern University Medical School, Chicago, Ill; Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC (Dr Lippman); and European Institute of Oncology, Milan, Italy (Dr Costa).

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RELATED LETTER

Estrogen-Receptor Status in Breast Cancer
Yen-Hong Kuo, Steven R. Cummings, Deborah Grady, Dennis Black, Stephen Eckert, Katheryn A. Krueger, Thomas Nickélsen, Joan E. Glusman, Trevor J. Powles, Jane A. Cauley, Larry Norton, Nina H. Bjarnason, Monica Morrow, V. Craig Jordan, Marc E. Lippman, and Alberto Costa
JAMA. 2000;283(3):338-339.
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