At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic breast adenocarcinoma with HER2 overexpression (3+ by IHC or gene amplification by FISH)
- ✓No prior chemotherapy for metastatic breast cancer; prior hormonal therapy for metastatic disease is allowed
- ✓ECOG performance status 0 or 1
- ✓At least one objective measurable disease parameter per RECIST criteria
- ✕Prior therapy with trastuzumab, ixabepilone, or carboplatin for metastatic disease; metastatic disease ≤6 months after completing adjuvant trastuzumab, paclitaxel, docetaxel, carboplatin, or ixabepilone is considered prior therapy
- ✕Untreated brain metastasis or brain metastasis currently undergoing radiation; brain metastasis as sole site of disease
- ✕Peripheral neuropathy of any grade
- ✕Prior severe (grade 3 or 4) hypersensitivity reaction to drug formulated in Cremophor EL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Trastuzumab Plus Weekly Ixabepilone(BMS-247550) and Carboplatin in Patients With HER2/Neu-Positive Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating trastuzumab, ixabepilone, and 2 other interventions for HER2-positive Breast Cancer and 3 related conditions. Completed, enrolled 61 participants across 1 site.
Detailed Summary
This phase II trial is studying how well giving trastuzumab together with ixabepilone and carboplatin works in treating patients with HER2/neu-positive metastatic breast cancer. 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 ixabepilone and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Correlative studies