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Carolyn J. Crandall, MD, MS; Aaron K. Aragaki, MS; Rowan T. Chlebowski, MD, PhD; Anne McTiernan, MD, PhD; Garnet Anderson, PhD; Susan L. Hendrix, DO; Barbara B. Cochrane, PhD, RN; Lewis H. Kuller, MD, DrPH; Jane A. Cauley, DrPH

Arch Intern Med. 2009;169(18):1684-1691.

Background  Estrogen plus progestin therapy increases breast cancer incidence and breast tenderness. Whether breast tenderness during estrogen plus progestin therapy is associated with breast cancer risk is uncertain.

Methods  We analyzed data from the Women's Health Initiative Estrogen + Progestin Trial, which randomized postmenopausal women with an intact uterus to receive daily conjugated equine estrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg (n = 8506), or placebo (n = 8102). At baseline and annually, participants underwent mammography and clinical breast examination. Self-reported breast tenderness was assessed at baseline and at 12 months. The incidence of invasive breast cancer was confirmed by medical record review (mean follow-up of 5.6 years).

Results  Of women without baseline breast tenderness (n = 14 538), significantly more assigned to receive conjugated equine estrogens plus medroxyprogesterone vs placebo experienced new-onset breast tenderness after 12 months (36.1% vs 11.8%, P < .001). Of women in the conjugated equine estrogens plus medroxyprogesterone group, breast cancer risk was significantly higher in those with new-onset breast tenderness compared with those without (hazard ratio, 1.48; 95% confidence interval, 1.08-2.03; P = .02). In the placebo group, breast cancer risk was not significantly associated with new-onset breast tenderness (P = .97).

Conclusions  New-onset breast tenderness during conjugated equine estrogens plus medroxyprogesterone therapy was associated with increased breast cancer risk. The sensitivity and specificity of the association between breast tenderness and breast cancer were similar in magnitude to those of the Gail model.

Trial Registration  clinicaltrials.gov Identifier: NCT00000611

Author Affiliations: Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles (Dr Crandall); Women's Health Initiative Clinical Coordinating Center (Mr Arakagi) and Division of Public Health Services (Drs McTiernan and Anderson), Fred Hutchinson Cancer Research Center, Seattle, Washington; Department of Hematology and Oncology, Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center (Dr Chlebowski); Department of Obstetrics and Gynecology, Wayne State University School of Medicine/Hutzel Women's Hospital, Detroit, Michigan (Dr Hendrix); Family and Child Nursing, University of Washington School of Nursing, Seattle (Dr Cochrane); and Department of Epidemiology, University of Pittsburgh, Pennsylvania (Drs Kuller and Cauley).

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