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

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

Detailed Description
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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.

Official Title
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A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Endostar
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endostar + chemotherapy<br>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. | Drug: Endostar<br>* an anti-angiogenesis drug<br>* Other names: Recombinant human endostatin;Drug: Chemotherapy<br>* Physician's choice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | From enrollment to disease progression or death due to any cause | up to approximately 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | From enrollment to death due to any cause | up to approximately 100 months | 
| Objective Response Rate (ORR） | Ratio of CR and PR in all subjects | up to approximately 100 months | 
| Clinical Benefit Rate (CBR) | Ratio of CR,PR and SD more than or equal to 24 weeks | up to approximately 100 months | 
| Adverse events (AEs) | Described in terms of CTC AE 4.0 | from enrollment to 30 days after the last dose administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, endostar