At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed invasive metastatic breast cancer
- ✓HER2/neu-positive by IHC (3+ by HercepTest) or FISH amplification positive
- ✓Prior anthracycline or taxane exposure as adjuvant or metastatic therapy
- ✓At least one measurable lesion ≥2.0 cm by CT/MRI or ≥1.0 cm by spiral CT
- ✕Bone metastases as the only evidence of metastasis
- ✕More than 1 prior chemotherapy regimen for advanced/metastatic disease
- ✕Prior capecitabine or oral fluoropyrimidines
- ✕Prior continuous (≥24 hours) fluorouracil infusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating trastuzumab, capecitabine, and 1 other intervention for Breast Cancer. Completed, enrolled 47 participants across 147 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.