Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: docetaxel and epirubicin
* Drug: docetaxel and epirubicin plus endostatin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chemotherapy<br>neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin | Drug: docetaxel and epirubicin<br>* docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles<br>* Other names: epirubicin, Pfizer;|
| Experimental: chemotherapy plus endostatin<br>neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin | Drug: docetaxel and epirubicin plus endostatin<br>* docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles<br>* Other names: recombinant human endostatin, Simcere Co. China;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical/pathological response |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, neoadjuvant chemotherapy, docetaxel, epirubicin, recombinant human endostatin (endostar), chemotherapy, endostatin