2 32 64.0    Negative 13 24.1 15 30.0    Unknown 2 3.7 3 6.0 HER-2 status            Positive            Negative            Unknown         Prior adjuvant chemotherapy** 20 37 21 42 Prior hormonal therapy            Adjuvant 35 64.8 30 60    Advanced 10 18.5 11 22 Disease free-interval (years)            < 1 10   11      1-5 30   28      >5 14   11   Dominant disease site            Viscera 40 74.0 32 64.0    Bone 11 20.4 9 18.0    Soft tissue 3 5.6 9 18.0 Number of disease site            1 23 42.6 23 46.0    2 23 42.6 18 36.0    ≥ 3 8 42.6 9 18.0 * HR: hormonal receptor status ** not including anthracyclines or

vinka alkaloids EV: epirubicin/vinorelbine; PLD/V: pegylated liposomal doxorubicin/vinorelbine Efficacy According to an intent to treat analysis, among 54 patients enrolled in arm A, there were 3 complete response (5.6%) and 20 partial responses (37%), for an overall response rate of 42.6% (95% CI, 29.3-55.9); Saracatinib price disease remained stable in 19 (35.2%), and progressive disease was observed in 6 (11.1%) patients. Among 50 patients enrolled in arm B, there were 8 complete responses (16%) and 18 partial responses (36%), for an overall response rate of 52% (95% CI, 38.2-65.8); disease remained stable in 12 (24%), and disease progression occurred in 9 (18%) patients (Table

2a). Six patients of arm A and 3 patients of arm B were not evaluable for response (4 refusal, 5 lost to follow up). selleckchem Stattic Objective response rates in 48 and 47 evaluable patients were 47.9% (95% CI, 33.9-61.9), and 55.3% (95% CI, 41.1-69.4) in the arm A and B, respectively (Table 2b). Disease control (CRs + PRs + NC) was 87.5% in arm A and 80.8% in arm B, respectively. Responses according to disease sites in evaluable patients are reported in details on Table 2c, and were as follows: arm A/B, soft tissue 66.6%/77.7%; bone 33.3%/37.5%; viscera 50%/53.3%. No relevant differences in response rate was observed according to hormonal

receptor status, evidencing only a trend of higher response in receptor negative tumors in both arms (53.6% vs 45.7%, arm A; 60% and 53.1% arm B). No differences in response rates have been observed by Her-2 status in both arms, but numbers are very small: arm A Her-2 neg 54%, Her-2 pos 42.8%; arm B Her-2 neg 64%, Her-2 pos 50%. Median time to response was 2 months in both arms (range, 1 to 4 months). Median progression free survival (Figure 1) was 10.7 months Mannose-binding protein-associated serine protease in arm A (95% CI, 8.7-12.6), and 8.8 months in arm B (95% CI 7.1-10.5), median overall survival (Figure 2) was 34.6 months in arm A (95%CI, 19.5-49.8) and 24.8 months in arm B (95% CI, 15.7-33.9). Table 2 Objective responses 2a. ITT on all enrolled patients   Arm A (EV) (54)   Arm B (PLD/V) (50)     No. %   No. %   CR 3 5.6 42.6% 8 16.0 52.0% PR 20 37.0 42.6% 18 36.0 52.0% NC 19 35.2   12 24.0   PD 6 11.1   9 18.0   2b. On evaluable patients   Arm A (EV) (54)   Arm B (PLD/V) (47)     No. %   No.