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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01423123 | Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer | PHASE1 | COMPLETED | 21 | — | — | May 1, 2011 | Mar 1, 2014 | Jul 8, 2014 | 4 | United States |
Number of patients experiencing dose limiting toxicities (DLT).
| Arm | Type | Description |
|---|---|---|
| Neratinib | EXPERIMENTAL | Paclitaxel (80 mg/m2 IV on days 1, 8, and 15 every 28 days) and trastuzumab (4 mg/kg/ loading dose, then 2 mg/kg) IV weekly beginning on day 1 of paclitaxel, neratinib orally daily beginning on day 1 of paclitaxel until disease progression. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | 80 mg/m2 IV on days 1, 8, and 15 every 28 days until disease progression. |
| trastuzumab | BIOLOGICAL | 4 mg/kg IV loading dose, then 2 mg/kg IV weekly until disease progression. |
| Neratinib | DRUG | Dose level 1: 120 mg/day orally; Dose level 2: 160 mg/day orally; Dose level 3: 240 mg/day orally; Dose level 4: 200 mg/day orally. |
Inclusion Criteria: * Co-morbid conditions should be taken into consideration, but not the diagnosis of metastatic breast cancer. * Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of ...