drugset / Trial / NCT01939054
Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients
Phase 2
Unknown
90 enrolled
Chinese Academy of Medical Sciences
Biotech Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine（TX）versus Docetaxel and Capecitabine（TX）as first-line treatment in patients with recurrent/metastatic triple negative breast cancer.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |