Study population characteristics are shown in table 1. Mean time from initial diagnosis to first relapse was 15.8 ± 6.5 months. Location of metastatic deposits includes bone (21/36), liver (21/36), lung (16/36),

lymphnodes (14/36) and local recurrence (3/36) with 27 out of 36 IWR-1 clinical trial patients presenting with multiple disease sites; remaining 9 patients with single-site metastasis presented with measurable non-bone disease. Patients receiving pre-operative chemotherapy, having a family Screening Library cost history of breast cancer or receiving docetaxel as part of adjuvant treatment were excluded as well as those for whom follow-up data were missing. Adjuvant treatment was performed in all patients but two as follow: 18 patients received an association of 5-fluorouracil (5-FU), epirubucin and cyclophosphamides (FEC) for 6 cycles, 11 patients received an association of epirubucin and cyclophosphamides (EC) for 4 cycles, and remaining 5 patients received an

association of cyclophosphamides, methotrexate and 5-FU (CMF) for 6 cycles. Table 1 Study population characteristics (n = 36) Median [range] age BGB324 ic50 (yr) 55 [37-87] Histotype #      Invasive ductal carcinoma 28 (77.7%)    Invasive lobular carcinoma 5 (13.8%)    Mixed (ductal and lobular) 2 (5.5%)    Undifferentiated 1 (3.0%) Grading°      G2 21 (58.3%)    G3 15 (41.7%) ER status      Negative 14 (38.8%)    Positive 22 (61.2%) PgR status      Negative 13 (36.1%)    Positive 23 (63.9%) HER2 status*      Negative 27 (75.0%)    Positive 9 (25.0%) Adjuvant chemotherapy^

     FEC 18 (52.9%)    EC 11 (32.4%)    CMF 5 (14.7%) Mean ± SD time to first relapse (months) 15.8 ± 6.5 Metastatis sites      Bone 21 (58.3%)    Liver 21 (58.3%)    Lung 16 (44.4%)    Lymphnodes 14 (38.8%)    Local 3 (8.3%) Chemotherapy”"      TXT75 14 (38.8%)    TXT25 8 (22.2%)    TXT75+C 5 (13.8%)    TXT75+T 9 (25.2%) Treatment best response      Complete response 1 (2.7%)    Partial response 14 (38.8%)    Stable disease 12 (33.3%)    Disease progression 9 (25.2%) Time to disease progression (months)      Median Rho [range] 9 [2-54] Overall survival (months)      Median [range] 20 [3-101] #According to WHO hystological typing of breast tumor (Ref. 32). °According to Elston and Ellis classification (Ref. 31). *Pre-study determination. “”See text for regimen details. ^on 34 pts. All patients received docetaxel-based first-line chemotherapy for metastatic disease. In particular, 14 out of 36 patients received six cycles docetaxel (75 mg/m2) every 3 weeks (TXT75), 8 patients received docetaxel (25 mg/m2) on a weekly basis (TXT25), 5 patients received a combination of docetaxel (75 mg/m2) on day 1 plus capecitabine (1000 mg/m2 bid day 1-14) every 3 weeks (TXT75+C) and the remaining 9 patients with HER2-positive disease received a combination of docetaxel (75 mg/m2) and trastuzumab (8 mg/kg loading dose then 6 mg/kg) both on day 1 every 3 weeks (TXT75+T) (Table 1).