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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00191451 | A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer | PHASE2 | COMPLETED | 150 | — | — | Apr 1, 2004 | Oct 1, 2008 | Nov 20, 2009 | 1 | United States |
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
| Arm | Type | Description |
|---|---|---|
| HER2+ | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. |
| HER2- (Taxane-) | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). |
| HER2- (Taxane+) | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients). |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) |
| Carboplatin | DRUG | Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Herceptin | DRUG | Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). |
Inclusion Criteria: 1. Diagnosis of metastatic breast cancer 2. Able to visit the doctor's office at least every 14 days during the actual treatment 3. Able to care for yourself, even if you cannot work or participate in other normal activities 4. Your blood results must be adequate for therapy. 5....