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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00043394 | CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer | PHASE2 | COMPLETED | 16 | — | — | Sep 1, 2002 | Oct 1, 2003 | Mar 12, 2009 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 0.04 mg/kg CpG 7909 |
| Cohort 2 | EXPERIMENTAL | 0.08 mg/kg CpG 7909 |
| Cohort 3 | EXPERIMENTAL | 0.12 mg/kg CpG 7909 Injection once weekly |
| Cohort 4 | EXPERIMENTAL | 0.16 mg/kg CpG 7909 |
| Name | Type | Description |
|---|---|---|
| 0.04 mg/kg CpG 7909 | DRUG | 0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| Herceptin® | DRUG | Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. |
| 0.08 mg/kg CpG 7909 | DRUG | 0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.12 mg/kg CpG 7909 | DRUG | 0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.16 mg/kg CpG 7909 | DRUG | 0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
Inclusion Criteria: * Histologically confirmed breast cancer with metastases * Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry * Patients may have had up to three prior chemotherapy regimens for metastatic disease, w...