Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

Detailed description:

Arms:
arm 1: Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. arm 2: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). arm 3: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).

Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Herceptin
Intervention descriptions: intervention 1: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) intervention 2: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). intervention 3: 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).

Protocol document: