NCT04452370Unknown2 期
Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- objective response rate（ORR）
研究概览
简要总结
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
详细描述
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 year-old women; TNBC
- •ECOG score: 0-1, expected survival time ≥ 3months;
- •Pathologically or cytologically confirmed breast cancer;
- •Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-3 standard chemotherapies after recurrence and metastasis;
- •According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination >2cm);
- •The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
- •Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L
- •Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis
- •Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance >50ml/min（Cockcroft-Gault formula)
- •Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration；
- •Can swallow oral drugs;
- •The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
排除标准
- •The patients in pregnancy or lactation growth period and did not take effective contraception;
- •The patients who received ≥4 chemotherapies after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
- •The patients with a variety of factors that affect the oral administration and absorption of drugs;
- •Prior treatment with etoposide or antiangiogenic TKI (subjects with prior use of antiangiogenic macromolecules such as bevacizumab are allowed to be enrolled);
- •The patients have uncontrollable mental illness；
- •Serous cavity effusion (such as pleural effusion and ascites) with clinical symptoms requiring clinical intervention or stable time less than 4 weeks;
- •The patients who had serious adverse effect to oral etoposide or were allergic to etoposide.
- •The patients who have only bone metastasis without other measurable lesion;
- •The patients experience severe cardiovascular diseases;
- •The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
- •Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L);
- •Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value);
- •Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
- •The patients have uncontrollable brain metastasis;
- •Active or uncontrolled infection requiring systematic treatment (except simple urinary tract infection or upper respiratory tract infection) during the 2 weeks or 2 weeks prior to enrollment;
- •Previous or concurrent history of other malignant tumors.Except for the cured skin basal cell carcinoma and cervical carcinoma in situ;
- •The patients do have good compliance to the therapy.
研究组 & 干预措施
oral Etoposide+Anlotinib
Experimental
anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle
干预措施: oral etoposide + anlotinib (Drug)
结局指标
主要结局
objective response rate（ORR）
时间窗: up to 1 year after the last patient enrolled
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
次要结局
- Progression free survival（PFS）(up to 1 year after the last patient enrolled)
- Incidence and Severity of adverse events(approximately 1.5 years)
研究者
Peng Yuan
Principal Investigator
Chinese Academy of Medical Sciences
研究点 (1)
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