A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
Conditions
Stage III Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: docetaxel, epirubicin and cyclophosphamide Type: Drug
Name: docetaxel, epirubicin and cyclophosphamide plus endostar Type: Drug
Overall Status
Not yet recruiting
Summary
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)

- Age 18-70

- No evidence of distant metastasis

- No previous therapy

- Normal hematologic function

- 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

- Being pregnant or nursing
Location
Start Date
August 2013
Completion Date
December 2015
Sponsors
Hebei Medical University Fourth Hospital
Source
Hebei Medical University Fourth Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page