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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