Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00807859 | Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer | PHASE1 | COMPLETED | 65 | — | — | Mar 9, 2009 | Oct 19, 2015 | Nov 8, 2022 | 23 | United States, Belgium +1 |
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | - |
| Cohort A3 | EXPERIMENTAL | - |
| Cohort B1 | EXPERIMENTAL | - |
| Cohort B3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMG 386 30 mg/kg, Paclitaxel and Trastuzumab | DRUG | AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W |
| AMG 386 30 mg/kg, Capecitabine and Lapatinib | DRUG | AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD |
| AMG 386 10 mgkg, Paclitaxel and Trastuzumab | DRUG | AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W |
| AMG 386 10 mg/kg, Capecitabine and Lapatinib | DRUG | AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD |
Inclusion Criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent. * HER2-positive by FISH, CISH, or IHC 3+ * ECOG performance status 0 or 1 * Left ventricular ejection f...