A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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～
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Endostar (Drug)
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.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to approximately 100 months
From enrollment to disease progression or death due to any cause
次要结局
- Objective Response Rate (ORR）(up to approximately 100 months)
- Overall Survival (OS)(up to approximately 100 months)
- Adverse events (AEs)(from enrollment to 30 days after the last dose administration)
- Clinical Benefit Rate (CBR)(up to approximately 100 months)
研究者
Xiaojia Wang(xj wang)
Director
Zhejiang Cancer Hospital