drugset / Trial / NCT00429104
Herceptin and GM-CSF for Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary Objectives: 1. To determine the patient's tumor response rate that this protocol will produce. 2. To determine the 1 year progression-free survival that this protocol will produce. Secondary Objective: 1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).
Timeline
- Start
- 2002-08
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |
| Subject | Trastuzumab | Monoclonal antibody | 4 mg/kg | Intravenous |