Table 1. Summary of 4 Randomized Controlled Trials of Breast Cancer Chemoprevention1

Study
(n)
Agent,
Dose
Median
Followup (mo.)
Breast
Cancer Types
Cases of Breast
Cancer (n)
Breast Cancer
Rate/1,000 woman-years
Relative
Risk (95% CI)
Placebo Treatment Placebo Treatment P value
Royal Marsden (19) (n=2,471,ages 30-70) Tamoxifen, 20 mg/d 70 All types 36 34 5.02 4.72 0.8 0.94
(0.59-1.43)
Italian Study (21,23) (n=5,408,ages 35-70) Tamoxifen, 20 mg/d 46 All types 22 19 2.32 2.12 0.64 0.873
(0.62-2.14)
ER+ 10 8 NA NA NA NA
81.2 All types 45 34 NA NA 0.215 HR4 0.75
(0.48-1.18)
Breast Cancer Prevention Trial (20) (n=13,388,ages 35+) Tamoxifen, 20 mg/d 54.6 Invasive 175 89 6.82 3.42 <0.00001 0.51
(0.39-0.66)
ER+ 130 41 NA NA NA 0.31
(0.22-0.45)
Noninvasive 69 35 2.72 1.42 <0.002 0.50
(0.33-0.77)
Multiple Outcomes of Raloxifene Evaluation (22,25) (n=7,705, median age 66.5) Raloxifene, 60 or 120 mg/d 40 All types 32 22 4.3 1.5 <0.001 0.35
(0.21-0.58)
Invasive 27 13 3.6 0.9 <0.001 0.24
(0.13-0.44)
ER+ 20 4 NA NA NA 0.10
(0.04-0.24)
48 All types 44 33 NA NA NA 0.38
(0.24-0.58)
Invasive 39 22 NA NA NA 0.28
(0.17-0.46)
ER+ 31 10 NA NA NA 0.16
(0.09-0.30)

1ER+, estrogen-receptor positive; CI, Confidence Interval; NA, Data not available.
2Data from reference (23).
3Calculated by authors.
4HR, hazard ratio, the estimate of relative risk at a given time.


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