Clinical trial · Interventional
Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer
Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer
NCT01479036CI-TRIAL-00005814CBCRT01unknownPhase 3ClinicalTrials.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 benefit breast cancer patients.
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
- docetaxel and epirubicin
- description
- DE chemotherapy alone
- interventionNames
- Drug: docetaxel and epirubicin
- type
- EXPERIMENTAL
- label
- docetaxel and epirubicin plus endostatin
- description
- chemotherapy plus endostatin
- interventionNames
- Drug: docetaxel and epirubicin plus endostatin
Primary outcomes (1)
- measure
- Clinical/pathological response
- timeFrame
- 3 years
- description
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)
- BACKGROUNDIn our previous phase Ⅱ trial (NCT00604435), the combination of rh-endostatin with docetaxel and epirubicin chemotherapy resulted in a higher objective response rate without increased toxicity in breast cancer patients, as compared with chemotherapy alone. Our results have been accepted to report as General Poster in ASCO's 47th Annual Meeting in 2011. Wang L, Chen JH, Yao Q, et al. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study. 2011 ASCO Annual Meeting Proceedings, J Clin Oncol 2011; 29(15s): 112s.
- DERIVEDChen J, Yao Q, Huang M, Wang B, Zhang J, Wang T, Ming Y, Zhou X, Jia Q, Huan Y, Wang J, Wang L. A randomized Phase III trial of neoadjuvant recombinant human endostatin, docetaxel and epirubicin as first-line therapy for patients with breast cancer (CBCRT01). Int J Cancer. 2018 May 15;142(10):2130-2138. doi: 10.1002/ijc.31217. Epub 2017 Dec 23. PMID 29238974