Status:
UNKNOWN
Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer
Lead Sponsor:
Xijing Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 hypoth...
Detailed Description
This is a multicenter, prospective, randomized, controlled phase Ⅲ clinical trial. A total of 800 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01479036
Start Date
October 1 2011
End Date
February 1 2015
Last Update
November 24 2011
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032