S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

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4/22/2013 Breast Cancer is a heterogeneous disease Perou, Nature 2000;406:747-752. Perou, The Oncologist 2010. Mechanisms of ER action in breast cancer Osborne, Annual Reviews 2011. BOLERO-2 Schema N = 724 • Postmenopausal 2 • ER+ HER2- MBC 2:1 • Recurrence or 1 progression to letrozole or anastrozole Everolimus 10 mg/day + Exemestane 25 mg/day (N = 485) Placebo + Exemestane 25 mg/day (N = 239) PFS OS ORR Bone Markers Safety QOL PK • Stratification: 1. Sensitivity to prior hormonal therapy 2. Presence of visceral disease No cross-over Baselga et al. ESMO 2011; Hortobagyi G et al. SABCS 2011, Baselga et al NEJM 2012. 2
4/22/2013 BOLERO‐2: Response & Clinical Benefit Exemestane + Everolumis Exemestane + Placebo 50.5% (%) Patients ( 12.0% P < 0.0001 P < 0.0001 25.5% 1.3% Response Clinical Benefit Baselga et al. ESMO 2011; Hortobagyi G et al. SABCS 2011, Baselga et al NEJM 2012, Piccart ASCO abstract 551. BOLERO ‐2: Primary Endpoint, PFS (18‐Month Follow‐up, Local) Probability (% %) of Event 100 80 60 40 20 EVE 10 mg + EXE PBO + EXE 0 EVE 10 mg + EXE (n/N=310/485) PBO + EXE (n/N=200/239) HR=0.45 (95% CI: 0.38-0.54) Log-rank p value: < .0001 EVE 10 mg + EXE: 7.82 months PBO + EXE: 3.19 months 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 114 120 Time (week) Number of patients still at risk 485 436 366 304 257 221 185 158 124 91 66 50 35 24 22 13 10 8 2 1 0 239 190 132 96 67 50 39 30 21 15 10 8 5 3 1 1 1 0 0 0 0 Piccart ASCO abstract 551. BOLERO ‐2: Primary Endpoint, PFS (18‐Month Follow‐up, Central) (%) of Event 100 80 60 HR=0.38 (95% CI: 0.31-0.48) Log-rank P value: < .0001 Kaplan-Meier medians EVE 10 mg + EXE: 11.01 months PBO + EXE: 4.14 months Probability 40 20 0 EVE 10 mg + EXE (n/N=188/485) PBO + EXE (n/N=132/239) 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 Time (week) Number of patients still at risk EVE 10 mg + EXE PBO + EXE 485 427 359 292 239 211 166 140 108 77 239 179 114 76 56 39 31 27 16 13 62 9 48 6 32 4 21 1 18 0 11 0 10 0 5 0 0 0 Piccart ASCO abstract 551. 3
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S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

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