Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Docetaxel; Endostatins; Epirubicin

Criteria

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