Raloxifene Hydrochloride (Page 7 of 9)

14.4 Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer

STAR Trial

The effects of raloxifene hydrochloride 60 mg/day versus tamoxifen 20 mg/day over 5 years on reducing the incidence of invasive breast cancer were assessed in 19,747 postmenopausal women in a randomized, double-blind trial conducted in North America by the National Surgical Adjuvant Breast and Bowel Project and sponsored by the National Cancer Institute. Women in this study had a mean age of 58.5 years (range 35 to 83), a mean 5-year predicted invasive breast cancer risk of 4.03% (range 1.66 to 23.61%), and 9.1% had a history of lobular carcinoma in situ (LCIS). More than 93% of participants were White. As of 31 December 2005, the median time of follow-up was 4.3 years (range 0.07 to 6.50 years).

Raloxifene hydrochloride was not superior to tamoxifen in reducing the incidence of invasive breast cancer. The observed incidence rates of invasive breast cancer were raloxifene hydrochloride 4.4 and tamoxifen 4.3 per 1000 women per year. The results from a noninferiority analysis are consistent with raloxifene hydrochloride potentially losing up to 35% of the tamoxifen effect on reduction of invasive breast cancer. The effect of each treatment on invasive breast cancer was consistent when women were compared by baseline age, history of LCIS, history of atypical hyperplasia, 5-year predicted risk of breast cancer by the modified Gail model, or the number of relatives with a history of breast cancer. Fewer noninvasive breast cancers occurred in the tamoxifen group compared to the raloxifene hydrochloride group. Table 9 presents efficacy and selected safety outcomes.

Table 9: Raloxifene Hydrochloride (60 mg Once Daily) vs . Tamoxifen (20 mg Once Daily) on Outcomes in Postmenopausal Women at Increased Risk for Invasive Breast Cancer
a Abbreviations: CI = confidence interval; DCIS = ductal carcinoma in situ; ER = estrogen receptor; IR = annual incidence rate per 1000 women; LCIS = lobular carcinoma in situ; RR = risk ratio for women in the raloxifene hydrochloride group compared with those in the tamoxifen group.
b Of the 60 noninvasive breast cases in the tamoxifen group, 5 were mixed types. Of the 83 noninvasive breast cancers in the raloxifene hydrochloride group, 7 were mixed types.
c Only patients with an intact uterus at baseline were included (tamoxifen = 4739, raloxifene = 4715).
d Only patients with at least one intact ovary at baseline were included (tamoxifen = 6813, raloxifene hydrochloride = 6787).
e Defined as myocardial infarction, severe angina, or acute ischemic syndromes.
f Only patients who were free of cataracts at baseline were included (tamoxifen = 8342, raloxifene hydrochloride = 8333).
g Peripheral edema events are included in the term edema.

Outcomes

Raloxifene Hydrochloride (N=9751)

Tamoxifen (N=9736)

RR (95% CI)a

n

IRa

n

IRa

Invasive breast cancer

173

4.40

168

4.30

1.02 (0.82, 1.27)

ERa positive

115

2.93

120

3.07

0.95 (0.73, 1.24)

ERa negative

52

1.32

46

1.18

1.12 (0.74, 1.71)

ERa unknown

6

0.15

2

0.05

2.98 (0.53, 30.21)

Noninvasive breast cancerb

83

2.12

60

1.54

1.38 (0.98, 1.95)

DCISa

47

1.20

32

0.82

1.46 (0.91, 2.37)

LCISa

29

0.74

23

0.59

1.26 (0.70, 2.27)

Uterine cancerc

23

1.21

37

1.99

0.61 (0.34, 1.05)

Endometrial hyperplasiac

17

0.90

100

5.42

0.17 (0.09, 0.28)

Hysterectomyc

92

4.84

246

13.25

0.37 (0.28, 0.47)

Ovarian cancerd

18

0.66

14

0.52

1.27 (0.60, 2.76)

Ischemic heart diseasee

138

3.50

125

3.19

1.10 (0.86, 1.41)

Stroke

54

1.36

56

1.42

0.96 (0.65, 1.42)

Deep vein thrombosis

67

1.69

92

2.35

0.72 (0.52, 1.00)

Pulmonary embolism

38

0.96

58

1.47

0.65 (0.42, 1.00)

Clinical vertebral fractures

58

1.46

58

1.47

0.99 (0.68, 1.46)

Cataractsf

343

10.34

435

13.19

0.78 (0.68, 0.91)

Cataract surgeryf

240

7.17

295

8.85

0.81 (0.68, 0.96)

Death

104

2.62

109

2.76

0.95 (0.72, 1.25)

Edemag

741

18.66

664

16.83

1.11 (1.00, 1.23)

Hot flashes

6748

169.91

7170

181.71

0.94 (0.90, 0.97)

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