Clinical trial · Interventional
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer
Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer
NCT00604435CI-TRIAL-00003044completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel and epirubicin | Drug | — | UNRESOLVED |
| docetaxel and epirubicin plus endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin
- interventionNames
- Drug: docetaxel and epirubicin
- type
- EXPERIMENTAL
- label
- chemotherapy plus endostatin
- description
- neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin
- interventionNames
- Drug: docetaxel and epirubicin plus endostatin
Primary outcomes (1)
- measure
- clinical/pathological response
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis) * Stage ⅡA-ⅢC * Age 18-70 * ECOG performance status 0-2 * No evidence of distant metastasis * No previous therapy * Normal hematologic function * left ventricular ejection fraction greater than 50 percent * No abnormality of renal or liver function * Written informed consent Exclusion Criteria: * With allergic constitution or possible allergic reflection to drugs to be used in this study * Any concurrent uncontrolled medical or psychiatric disorder * History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease. * History of bleeding diathesis * Being pregnant or nursing
References
Publications (2)
- BACKGROUNDLi 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. PMID 17705027
- DERIVEDChen 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. PMID 23693018