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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Chemotherapy; Drug: Endostar

Study type: Interventional

Funder types: Other

Identifiers

NCT03907098

ZJCHBC008

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

endostar + chemotherapy

Experimental group

Description:

Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks. Chemotherapy regimens are selected by physicians based on regular clinical decision.

Treatment:

Drug: Endostar

Drug: Chemotherapy