tment for patients in the study was 5 years, but the trial was terminated early because of an interim analysis showing a favorable Femara effect on time without recurrence or contralateral breast cancer. At the time of unblinding, women had been followed for a median of 28 months, 30% of patients had completed 3 or more years of follow-up and less than 1% of patients had completed 5 years of follow-up.
Selected baseline characteristics for the study population are shown in Table 7.
Table 7: Selected Study Population Demographics (Modified ITT Population) Baseline Status Femara Placebo
N=2582 N=2586
Hormone Receptor Status (%)
ER+ and/or PgR+ 98 98
Both Unknown 2 2
Nodal Status (%)
Node Negative 50 50
Node Positive 46 46
Nodal Status Unknown 4 4
Chemotherapy 46 46
Table 8 shows the study results. Disease-free survival was measured as the time from randomization to the earliest event of loco-regional or distant recurrence of the primary disease or development of contralateral breast cancer or death. DFS by hormone receptor status, nodal status and adjuvant chemotherapy were similar to the overall results. Data were premature for an analysis of survival.
Table 8: Extended Adjuvant Study Results Femara
N = 2582 Placebo
N = 2586 Hazard Ratio
(95% CI) P-Value
Disease Free Survival (DFS)1 Events 122 (4.7%) 193 (7.5%) 0.62 (0.49, 0.78)2 0.00003
Local Breast Recurrence 9 22
Local Chest Wall Recurrence 2 8
Regional Recurrence 7 4
Distant Recurrence 55 92 0.61 (0.44 - 0.84) 0.003
Contralateral Breast Cancer 19 29
Deaths Without Recurrence or Contralateral Breast Cancer 30 38
CI = confidence interval for hazard ratio. Hazard ratio of less than 1.0 indicates difference in favor of Femara (lesser risk of recurrence); hazard ratio greater than 1.0 indicates difference in favor of placebo (higher risk of recurrence with Femara).
1 First event of loco-regional recurrence, distant relapse, contralateral breast cancer or death from any cause
2 Analysis stratified by receptor status, nodal status and prior adjuvant chemotherapy (stratification factors as at randomization). P-value based on stratified logrank test.
14.3 Updated Analyses of Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 MonthsTable 9: Update of Extended Adjuvant Study Results Femara
N = 2582
(%) Placebo
N = 2586
(%) Hazard Ratio1
(95% CI) P-Value2
Disease Free Survival (DFS) events3 344 (13.3) 402 (15.5) 0.89 (0.77, 1.03) 0.12
Breast cancer recurrence
(Protocol definition of DFS events4) 209 286 0.75 (0.63, 0.89) 0.001
Local Breast Recurrence 15 44
Local Chest Wall Recurrence 6 14
Regional Recurrence 10 8
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