A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer (TENDENCY)

Hebei Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Stage III Breast Cancer

Treatments

Drug: docetaxel, epirubicin and cyclophosphamide

Drug: docetaxel, epirubicin and cyclophosphamide plus endostar

Study type

Interventional

Funder types

Other

Identifiers

NCT01907529

HBMUFH-101

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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