Table 1 Updated results from major randomized controlled trials of selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) for breast cancer preventive therapy
From: How do we increase uptake of tamoxifen and other anti-estrogens for breast cancer prevention?
Trial | No. of participants | Study population | Agents | Breast cancer risk reduction RR or HR (95% CI) | Toxicities compared to controls (Rate per 1000) |
|---|---|---|---|---|---|
BCPT, 2005 (ref. 5) | 13,388 | Age ≥ 35 years, 5-yr Gail risk score > 1.66% if age 35-59 years or age ≥ 60 years or LCIS | Tamoxifen 20 mg/day × 5 years vs. placebo | 0.57 (0.46–0.70) | Endometrial cancer (2.24 vs. 0.68) |
Stroke (1.75 vs. 1.23) | |||||
Thromboembolism (1.90 vs. 1.16) | |||||
IBIS-I, 2014 (ref. 6) | 7154 | Age 35–70 years, tenfold risk if age 35–39 years or fourfold risk if age 40–44 years or twofold risk if age 45–70 years | Tamoxifen 20 mg/day × 5 years vs. placebo | 0.71 (0.60–0.83) | Endometrial cancer (8.10 vs. 5.59) |
Stroke (8.38 vs. 7.83) | |||||
Thromboembolism (13.97 vs. 8.11) | |||||
19,490 | Age ≥ 35 years, postmenopausal, 5-year Gail risk score > 1.66% | Raloxifene 60 mg/day vs. Tamoxifen 20 mg/day × 5 years | 1.19 (1.04–1.37)* | Endometrial cancer (1.23 vs. 2.25) | |
Thromboembolism (2.47 vs. 3.30) | |||||
Cataracts (11.69 vs. 14.58) | |||||
MAP.3, 2011 (ref. 8) | 4560 | Age ≥ 35 years, postmenopausal, 5-year Gail risk score > 1.66% if age 35–59 years or age ≥ 60 years or AH, LCIS, DCIS with mastectomy | Exemestane 25 mg/day × 5 years vs. placebo | 0.35 (0.18–0.70) | Fractures (66.51 vs. 63.60) |
Cardiovascular events (47.32 vs. 49.37) | |||||
IBIS-II, 2014 (ref. 9) | 3864 | Age 40–70 years, postmenopausal, fourfold risk if age 40–44 years or twofold risk if age 45–59 years or 1.5-fold risk if age 60–70 | Anastrozole 1 mg/day × 5 years vs. placebo | 0.47 (0.32–0.68) | Fractures (85.42 vs. 76.65) |
Cardiovascular events (66.67 vs. 48.87) |
