At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the breast with metastatic disease
- ✓HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)
- ✓Measurable or evaluable disease
- ✓Age 18 and over
- ✕Prior trastuzumab for metastatic breast cancer
- ✕Prior docetaxel for metastatic breast cancer
- ✕Prior monoclonal antibodies directed at EGFR
- ✕Prior EGFR-directed therapy (tyrosine kinase inhibitors)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of ZD1839 (Iressa®), Trastuzumab (Herceptin®), and Docetaxel (Taxotere®) in Patients With erbB-2 (HER-2) Overexpressing, Stage IV Breast Carcinoma
In Brief
A Phase 2 clinical trial evaluating trastuzumab, docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 31 participants across 6 sites.
Detailed Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells. PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer.
Study Details
Timeline
Interventions
Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.
75 mg/m2 every three weeks, or 60 mg/m2 every three weeks depending on study findings
250 mg daily or 250 mg daily on days 2 through 14 depending on study findings