Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer
2018年11月7日 更新者:Li Qiao、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The Efficacy and Safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer :Single Arm, Phase II Clinical Trail
The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
研究概览
详细说明
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment.
Advanced patients have shorter survival than other subtypes.
Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes.
Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks.
Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC.
Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer.
Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
研究类型
介入性
注册 (预期的)
29
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Beijing
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Beijing、Beijing、中国、100021
- 招聘中
- Cancer Hospital, ChineseAMS
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接触:
- Qiao LI, MD
- 电话号码:86-10-87788120
- 邮箱:liqiaopumc@yahoo.cn
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接触:
- Binghe XU, MD, PHD
- 电话号码:86-10-87788495
- 邮箱:xubinghe@medmail.com.cn
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Age between 18 and 75 year-old women;
- Physical condition ECOG PS: 0-1;
- Previously untreated, histologically or cytologically confirmed to be triple negative breast cancer;
- Breast mass > 2cm, or ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicle); Note: According to RECIST version 1.1, confirmed by CT or MRI,There must be at least one measurable lesion;If the target lesion is a lymph node requiring a short diameter greater than 1.5 cm, and the target lesion is not suitable for surgical treatment;
- Laboratory tests meet the following criteria: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥10g/dl; serum bilirubin ≤ 1.5 times the upper limit of normal value; AKP,ALT and AST≤2.5 times the upper limit of normal value;AKP, ALT and AST≤5 times the upper limit of normal value when liver metastasis;Urea nitrogen ≤ 1.5 times the upper limit of normal value,serum creatinine ≤ 1.5 times the upper limit of normal value;
- Expected survival time ≥ 3 months;
- 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;
- Patients volunteered to join the study and signed informed consent.
Exclusion Criteria:
- There are other metastasis sites other than ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicular);
- Have received anti-tumor treatment;
- Patients with hypertension who are not well controlled by antihypertensive medication (systolic pressure >140 mmHg, diastolic pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as Refractory angina pectoris,congestive heart failure occurred within 6 months prior to screening ; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, prolonged QT interval; history of cerebrovascular accident, symptomatic and medication required Coronary heart disease;
- Significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with previous bleeding history, clinically significant bleeding symptoms, and patients with clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + and above, vasculitis, etc.; urine protein positive patients;
- Major surgery or severe traumatic injury, fracture, or poor healing wound within 4 weeks;
- Allergic to apatinib and/or its adjuvants, paclitaxel, carboplatin, etc.;
- Female patients during pregnancy or lactation, female patients with fertility and pregnancy test positive, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period
- The patient has a severe concomitant disease, or any other condition the investigator believes is not suitable for the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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 |
---|---|
实验性的:apatinib+Paclitaxel+Carboplatin
apatinib 250mg, d1-14,14day/cycle; Paclitaxel 175mg/m2,d1,14days/cycle; Carboplatin AUC=4,d1,14day/cycle
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apatinib 250mg,qd,d1-14,14day/cycle
paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle
carboplatin AUC=4,d1,14day/cycle;
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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 |
---|---|---|
pCR rate
大体时间:3 months
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pCR defined as no invasive and non-invasive (DCIS) residuals in breast and armpit lymph nodes
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3 months
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safety of treatment: Incidence of adverse events
大体时间:every 2 weeks
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Incidence of adverse events by maximum CTCAE grade (v4.03;
NCI 2010)
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every 2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
rate of breast-pCR
大体时间:3 months
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breast-pCR defined as no invasive and non-invasive (DCIS) residuals in breast
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3 months
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DFS
大体时间:up to 2 years
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DFS defined as the time from drug onset until recurrence or death for various reasons.
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up to 2 years
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Rate of breast conserving surgery
大体时间:3 months
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Rate of patients with breast conserving surgery
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Qiao Li、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年11月1日
初级完成 (预期的)
2020年6月1日
研究完成 (预期的)
2020年6月1日
研究注册日期
首次提交
2018年11月5日
首先提交符合 QC 标准的
2018年11月7日
首次发布 (实际的)
2018年11月8日
研究记录更新
最后更新发布 (实际的)
2018年11月8日
上次提交的符合 QC 标准的更新
2018年11月7日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Apatinib的临床试验
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Sun Yat-sen UniversityJiangsu Hengrui Pharmaceutical Co., Ltd.尚未招聘