drugset / Trial / NCT00604435
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer
RandomizedParallel-groupSingle-blindTreatment
Summary
This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-01
- Completion
- 2010-01
Publications
- Background Li J, Dong X, Xu Z, Jiang X, Jiang H, Krissansen GW, Sun X. Endostatin gene therapy enhances the efficacy of paclitaxel to suppress breast cancers and metastases in mice. J Biomed Sci. 2008 Jan;15(1):99-109. doi: 10.1007/s11373-007-9201-3. Epub 2007 Aug 18.
- Chen J, Yao Q, Li D, Zhang J, Wang T, Yu M, Zhou X, Huan Y, Wang J, Wang L. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study. BMC Cancer. 2013 May 21;13:248. doi: 10.1186/1471-2407-13-248.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Endostar | Protein / enzyme biologic | 7.5 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 60 mg/m2 | Intravenous |