Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Endostar protein; Endostatins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.