Overview

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.