Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
Study Details
Study Description
Brief Summary
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: endostar + chemotherapy 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
an anti-angiogenesis drug
Other Names:
Drug: Chemotherapy
Physician's choice
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [up to approximately 100 months]
From enrollment to disease progression or death due to any cause
Secondary Outcome Measures
- Overall Survival (OS) [up to approximately 100 months]
From enrollment to death due to any cause
- Objective Response Rate (ORR） [up to approximately 100 months]
Ratio of CR and PR in all subjects
- Clinical Benefit Rate (CBR) [up to approximately 100 months]
Ratio of CR,PR and SD more than or equal to 24 weeks
- Adverse events (AEs) [from enrollment to 30 days after the last dose administration]
Described in terms of CTC AE 4.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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locoregionally Recurrent or metastatic breast cancer confirmed by histology.
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HER-2 Negative Breast Cancer.
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At least one measurable lesion according to RECIST 1.1..
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Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.
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18-70 years old.
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ECOG PS 0～1.
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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.
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life expectancy is not less than 12 weeks.
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Signed informed consent.
Exclusion Criteria:
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Uncontrolled central nervous system metastasis.
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Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..
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History of allergy to biological agents in the past.
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Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.
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Pregnant or lactating women..
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The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.
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The risk of uncontrolled infection, thrombosis and bleeding exists.
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A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
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Researchers consider it inappropriate to carry out the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZJCHBC008