Anlotinib in Metastatic HER2 Negative Breast Cancer
The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial
研究概览
详细说明
Breast cancer is one of the most common malignant tumors in women, which is a serious threat to women's health. Despite the continuous improvement of treatment, 30% of breast cancer eventually develops into advanced breast cancer. The median survival of advanced breast cancer after routine treatment is 2-3 years. The main treatments include chemotherapy, endocrine therapy, and targeted therapy. The treatment of metastatic breast cancer (MBC) aims to improve quality of life, reduce pain and prolong survival.
Angiogenesis plays an important role in tumor cell proliferation and metastasis. Various anti-angiogenic drugs such as bevacizumab, sunitinib, sorafenib, etc. have been developed and widely used in various tumors. Treatments such as colon cancer, lung cancer, and renal cell carcinoma significantly improve PFS and OS in patients with advanced disease, and the adverse reactions are well tolerated. However, anti-angiogenic therapy has certain limitations in the treatment of advanced breast cancer.
Anrotinib hydrochloride capsule is a new drug independently developed in China. It is a multi-target receptor tyrosine kinase inhibitor targeting angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3 and other kinases such as cell growth-related kinases such as PDGFRα/β, c-Kit, and Ret , and it was approved by China Food and Drug Administation for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have progressed or relapsed after receiving at least 2 systemic chemotherapy. Basic research shows that anlotinib is effective in breast cancer cell lines, but lacks the results of clinical application of advanced breast cancer. This study is based on the results of phase I clinical trials of allerinib in a variety of advanced solid tumors, to explore its efficacy and safety in HER2-negative advanced breast cancer.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100021
- National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
- ECOG score: 0-1, expected survival time ≥ 3months;
- Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 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.
Exclusion Criteria:
- The patients in pregnancy or lactation growth period and did not take effective contraception;
- The patients who received ≥3 chemotherapies(Do not include endocrine therapy)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;
- The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area or liver dysfunction);
- The patients have uncontrollable mental illness.
- 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;
- The patients do not have good compliance to the therapy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:anlotinib
anlotinib 12mg qd p.o. d1-14/21day/cycle
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Anlotinib 12mg p.o. d1-14, 21days/cycle
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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objective response rate(ORR)
大体时间:through study completion, an average of 1 year
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Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria.
CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
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through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
疾病控制率(DCR)
大体时间:通过学习完成,平均1年
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根据 RESIST 标准 v1.1,接受安罗替尼治疗的疾病稳定或部分反应或完全反应的参与者人数。
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通过学习完成,平均1年
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无进展生存期 (PFS)
大体时间:从入组之日到第一次记录的进展之日,评估长达 24 个月
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使用 Kaplan-Meier 方法估计的无进展生存期定义为从知情同意日期到死亡或疾病进展较早日期的时间。
没有疾病进展的活着的患者在最后一次疾病评估的日期被删失。
基于 RECIST 1.1 的进展性疾病 (PD) 是指目标病灶的最长直径 (LD) 总和至少增加 20%,以自治疗开始以来记录的最小总 LD 或出现一个或多个新病灶作为参考。
非目标病变的模棱两可的进展也符合 PD 的条件。
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从入组之日到第一次记录的进展之日,评估长达 24 个月
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总生存期(OS)
大体时间:从入组之日到死亡,评估长达 24 个月
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OS,定义为从知情同意之日到死亡之日的时间,与死亡原因无关。
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从入组之日到死亡,评估长达 24 个月
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Safety and Tolerability
大体时间:through study completion, an average of 1 year
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All the treatment-related adverse events occurred as assessed by CTCAE v4.0
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through study completion, an average of 1 year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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circulating tumor DNA biomarker
大体时间:From date of enrollment until the date of first documented progression, assessed up to 24 months
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biomarkers measurement in dynamic circulating tumor DNA sequencing on the day of enrollment and at the end of every two cycle (28 days one cycle)
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From date of enrollment until the date of first documented progression, assessed up to 24 months
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Hunan Province Tumor Hospital尚未招聘
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Hunan Province Tumor Hospital尚未招聘
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