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New-Onset Breast Tenderness After Initiation of Estrogen Plus Progestin Therapy and Breast Cancer Risk
Archives of Internal Medicine, 10/13/09

Crandall CJ et al. – 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.

Methods

Data was analyzed from Women's Health Initiative Estrogen + Progestin Trial, which randomized postmenopausal women with intact uterus to receive daily conjugated equine estrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg , or placebo
At baseline and annually, participants underwent mammography and clinical breast examination
Self-reported breast tenderness assessed at baseline and 12 mos
Incidence of invasive breast cancer confirmed by medical record review (mean follow-up of 5.6 y)

Results

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 mos (36.1% vs 11.8%)
Of women in conjugated equine estrogens plus medroxyprogesterone group, breast cancer risk was significantly higher in those with new-onset breast tenderness compared with those without)
In placebo group, breast cancer risk not significantly associated with new-onset breast tenderness