NCT03080805Unknown3 期
A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged ≥18 and ≤70 years.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •According to RECIST 1.1, at least one measurable lesion exists
- •Histologically or cytologic confirmed HER2 positive metastatic breast cancer.
- •Prior treatment with trastuzumab (≥2 cycles in metastatic setting, or
- •≥3 months in adjuvant/neoadjuvant setting) and Taxane(≥2 cycles in any setting or untill unendurable AE or progression during treatment).
- •Previously reveived ≤2 chemotherapy regimens in metastasis setting;
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: ≤5 x ULN); BUN and Creatinine:
- •≤ 1x ULN;CCR≥50 mL/min;LVEF: ≥ 50%;QTcF: < 450 ms (male)，< 470 ms（female）;
- •Signed informed consent.
排除标准
- •Received capecitabine in metastatic setting;
- •Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib);
- •Cumulated dosage of Doxorubincin >400 mg/m^2 or Epirubicin >800 mg/m^2 or equal dosage of other anthracycline drugs in adjuvant/neoadjuvant/metastatic setting );
- •Received surgery，chemotherapy,radiotherapy or target therapy within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization;
- •Participated in other clinical trial within 28 days prior to randomization.
- •Known dihydro pyrimidine dehydrogenase（DPD）defect;
- •CT or MRI confirmed brain metastases;
- •Bone or skin lesion as unique target lesion;
- •Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
- •Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
- •Uncontrolled third space effusion (such as pleural fluid and ascites) by drainage or other clinical intervention;
- •Receiving any other anti-tumour therapy after informed consent;
- •Unprogressed after or during the last anti-tumour therapy,according to RECIST1.1;
- •History of any kind of Heart disease,including 1)Angina pectoris; (2) Arrhythmia required medication or with clinical significance; (3) Myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by researcher as not suitable for participating in this study, etc;
- •History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation;
- •History of neurological or psychiatric disorders, including epilepsy or dementia;
- •Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study;
- •All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study;
- •Any other situations judged by investigator as not suitable for participating in this study.
研究组 & 干预措施
Lapatinib Plus Capecitabine
Active Comparator
干预措施: Lapatinib Plus Capecitabine (Drug)
Pyrotinib Plus Capecitabine
Experimental
干预措施: Pyrotinib Plus Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: Estimated 10 months
From infromed consent to progression or death
次要结局
- Safety: AE(AE recorded from infromed consent to 28 days after treatment completion)
- Overall Survival (OS)(Estimated 30 months)
- Objective Response Rate (ORR)(Estimated 10 months)
- Time to Progression (TTP)(Estimated 10 months)
- Duration of Response (DOR)(Estimated 10 months)
- Clinical Benefit rate (CBR)(Estimated 10 months)
研究者
研究点 (1)
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