| 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 0.45Â mg/BZA 20Â mg and 0.625Â mg/BZA 20Â mg were significantly lower than with CE 0.45Â mg/MPA 1.5Â 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 2Â years: CE 0.45Â mg/BZA 20Â mg, 13 (4.4%) | ND | ND | ND | n (%) at 1Â year: CE 0.45Â mg/BZA 20Â mg, 4 (0.9%) |
CE 0.625Â mg/BZA 20Â mg, 11 (4.2%) | CE 0.625Â mg/BZA 20Â mg, 2 (0.4%) | ||||
RLX 60Â mg, 9 (3.4%) | BZA 20Â mg, 1 (0.4%) | ||||
PBO, 7 (2.6%) [100] | CE 0.45Â mg/MPA 1.5Â 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 0.45Â mg/BZA 20Â mg or 0.625Â mg/BZA 20Â mg; CE 0.45Â mg/MPA 1.5Â mg significantly increased breast density vs. PBO (P <0.001) |
Mean (SD) percentage change from baseline in percentage breast density at 2Â years: CE 0.45Â mg/BZA 20Â mg, -0.39% (1.75%) | |||||
Adjusted percentage change from baseline in percentage breast density at 1Â year, mean (SD): CE 0.45Â mg/BZA 20Â mg, -0.38% (0.22%) | |||||
CE 0.625Â mg/BZA 20Â mg, -0.05% (1.68%) | |||||
RLX 60Â mg, -0.23% (1.76%) | |||||
PBO, -0.42% (1.72%) [100] | CE 0.625Â mg/BZA 20Â mg, -0.44% (0.22%) | ||||
BZA 20Â mg, -0.24% (0.30%) | |||||
CE 0.45Â mg/MPA 1.5Â mg, 1.60% (0.35%) | |||||
PBO, -0.32% (0.23%) [18] |