drugset / Trial / NCT01097642
Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
Phase 2
Completed
40 enrolled
The Methodist Hospital Research Institute
Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients with metastatic breast cancer after failing other treatments. Cetuximab is active against tumors expressing epidermal growth factor receptor w/demonstrated activity in head \& neck and colorectal tumors and may be effective in some breast cancers known to express EGFR. Study seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).
Timeline
- Start
- 2008-10-10
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Ixabepilone | Small molecule | 40 mg/m2 | Intravenous |