This is a multi-center phase II open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic HER-2 negative breast cancer.
Endostar is an anti-angiogenesis drug. It is prepared by adding 9 amino acids to the N-terminal of the peptide chain on the basis of endostatin. Studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
locoregionally Recurrent or metastatic breast cancer confirmed by histology.
HER-2 Negative Breast Cancer.
At least one measurable lesion according to RECIST 1.1..
Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.
18-70 years old.
ECOG PS 0～1.
Participants must have normal organ and marrow function as defined below: ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
life expectancy is not less than 12 weeks.
Signed informed consent.
You may not be if
Uncontrolled central nervous system metastasis.
Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..
History of allergy to biological agents in the past.
Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.
Pregnant or lactating women..
The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.
The risk of uncontrolled infection, thrombosis and bleeding exists.
A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
Researchers consider it inappropriate to carry out the study.
Clareo Health | Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
