Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: docetaxel and epirubicin; Drug: docetaxel and epirubicin plus endostatin

• Registration Number: NCT00604435
• Lead Sponsor: Xijing Hospital

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 hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.

Detailed Description

This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.

Study Timeline

• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-01-30
• Study Start: 2008-02
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-18
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy	docetaxel and epirubicin	neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin
chemotherapy plus endostatin	docetaxel and epirubicin plus endostatin	neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin

Primary Outcome Measures

Name	Time	Method
clinical/pathological response	one year

Secondary Outcome Measures

Name	Time	Method
safety and tolerability	one year

Trial Locations

Locations (1)

Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China