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Table 3 Breast safety results from the SMART clinical trial program

From: Breast-related effects of selective estrogen receptor modulators and tissue-selective estrogen complexes

  SMART-1 SMART-2 SMART-3 SMART-4 SMART-5
Breast pain/tenderness No significant differences in incidence of breast pain for any dose of CE/BZA, RLX 60 mg, or PBO [10] No significant difference in number of women reporting ≥1 day of breast pain between CE/BZA and PBO [13] Incidence of breast pain with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg not significantly different from PBO [15] No significant difference in number of women reporting ≥1 day of breast pain between CE/BZA and PBO Rates of breast tenderness with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg from 5.8%-9.4%, similar to PBO (5.4%-8.6%) [18]
Rates of breast tenderness with CE 0.45 mg/BZA 20 mg and 0.625 mg/BZA 20 mg were significantly lower than with CE 0.45 mg/MPA 1.5 mg (7.3%-24.3%; P <0.001) [18]
Compared with CE 0.45 mg/MPA 1.5 mg, breast pain incidence was significantly lower with CE 0.45 mg/BZA 20 mg at weeks 5–8 and 9–12 (P <0.05) and for CE 0.625 mg/BZA 20 mg at weeks 1–4, 4–8, and 9–12 (P <0.01) [17]
Abnormal mammogram findings n (%) at 2 years: CE 0.45 mg/BZA 20 mg, 13 (4.4%) ND ND ND n (%) at 1 year: CE 0.45 mg/BZA 20 mg, 4 (0.9%)
CE 0.625 mg/BZA 20 mg, 11 (4.2%) CE 0.625 mg/BZA 20 mg, 2 (0.4%)
RLX 60 mg, 9 (3.4%) BZA 20 mg, 1 (0.4%)
PBO, 7 (2.6%) [100] CE 0.45 mg/MPA 1.5 mg, 3 (1.4%)
PBO, 1 (0.2%) [18]
Breast density changes No significant differences between groups in breast density ND ND ND No significant differences from PBO with CE 0.45 mg/BZA 20 mg or 0.625 mg/BZA 20 mg; CE 0.45 mg/MPA 1.5 mg significantly increased breast density vs. PBO (P <0.001)
Mean (SD) percentage change from baseline in percentage breast density at 2 years: CE 0.45 mg/BZA 20 mg, -0.39% (1.75%)
Adjusted percentage change from baseline in percentage breast density at 1 year, mean (SD): CE 0.45 mg/BZA 20 mg, -0.38% (0.22%)
CE 0.625 mg/BZA 20 mg, -0.05% (1.68%)
RLX 60 mg, -0.23% (1.76%)
PBO, -0.42% (1.72%) [100] CE 0.625 mg/BZA 20 mg, -0.44% (0.22%)
BZA 20 mg, -0.24% (0.30%)
CE 0.45 mg/MPA 1.5 mg, 1.60% (0.35%)
PBO, -0.32% (0.23%) [18]
  1. BZA, bazedoxifene; CE, conjugated estrogens; MPA, medroxyprogesterone acetate; ND, not determined; PBO, placebo; RLX, raloxifene; SD, standard deviation; SMART, Selective estrogens, Menopause, And Response to Therapy.
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