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For most participants, multiple risk factors would have been required for eligibility. This table considers risk factors individually, regardless of other co-existing risk factors, for women who developed breast cancer. The 5-year predicted absolute breast cancer risk accounts for multiple risk factors in an individual and should provide the best estimate of individual benefit (See INDICATIONS AND USAGE ). Major Outcomes of the NSABP P-1 Trial. TYPE OF EVENT # OF EVENTS RATE/1000 WOMEN/YEAR 95% CI PLACEBO Tamoxifen CITRATE PLACEBO Tamoxifen CITRATE RR LIMITS Invasive Breast Cancer 156 86 6. First Degree Relatives 0 32 17 5. Table 4 describes the characteristics of the breast cancers in the NSABP P-1 trial and includes tumor size, nodal status, ER status. Tamoxifen citrate decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. Characteristics of Breast Cancer in NSABP P-1 Trial, sucralfate 100 mg/ml suspension. Staging Parameter Placebo N=156 Tamoxifen N=86 Total N=242 Tumor Size: T1 117 60 177 T2 28 20 48 T3 7 3 10 T4 1 2 3 Unknown 3 1 4 Nodal status: Negative 103 56 159 1 to 3 positive nodes 29 14 43 ?4 positive nodes 10 12 22 Unknown 14 4 18 Stage: I 88 47 135 II: node negative 15 9 24 II: node positive 33 22 55 III 6 4 10 IV 2 1 1 3 Unknown Estrogen receptor: Positive 12 115 3 38 15 153 Negative 27 36 63 Unknown 14 12 26 1 One participant presented with a suspicious bone scan but did not have documented metastases. She subsequently died of metastatic breast cancer. Interim results from 2 trials in addition to the NSABP P-1 trial examining the effects of Tamoxifen in reducing breast cancer incidence have been reported. The first was the Italian Tamoxifen Prevention trial. In this trial women between the ages of 35 and 70, who had had a total hysterectomy, were randomized to receive 20 mg Tamoxifen or matching placebo for 5 years. The primary endpoints were occurrence of, and death from, invasive breast cancer. Women without any specific risk factors for breast cancer were to be entered. Between 1992 and 1997, 5408 women were randomized. Hormone Replacement Therapy (HRT) was used in 14% of participants. The trial closed in 1997 due to the large number of dropouts during the first year of treatment (26%). After 46 months of follow-up there were 22 breast cancers in women on placebo and 19 in women on Tamoxifen. Although no decrease in breast cancer incidence was observed, there was a trend for a reduction in breast cancer among women receiving protocol therapy for at least 1 year (19-placebo, 11- Tamoxifen). The small numbers of participants along with the low level of risk in this otherwise healthy group precluded an adequate assessment of the effect of Tamoxifen in reducing the incidence of breast cancer. The second trial, the Royal Marsden Trial (RMT) was reported as an interim analysis. The RMT was begun in 1986 as a feasibility study of whether larger scale trials could be mounted. The trial was subsequently extended to a pilot trial to accrue additional participants to further assess the safety of Tamoxifen.
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