A Single-arm, Multi-center Phase II Clinical Study of Pyrotinib Combined With Vinorelbine in the Treatment of HER2-positive and Treated Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- PFS as Assessed by the Investigator
研究概览
简要总结
The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer.
The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.
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
- •Histologically or cytologically confirmed invasive breast cancer
- •HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
- •Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent. Patients who have previously used pertuzumab will be allowed.
- •Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
- •Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
- •Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •History of treatment with pyrotinib
- •Prior treatment with lapatinib or neratinib
- •History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma
- •History of receiving any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy
- •Recovery of treatment-related toxicity consistent with other eligibility criteria
- •History of radiation therapy within 28 days of randomization
- •Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
- •History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
- •History of myocardial infarction or unstable angina
- •Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
- •Pregnancy or lactation
- •Current known active infection with human immunodeficiency virus (HIV) or hepatitis C virus
- •Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
研究组 & 干预措施
Pyrotinib plus vinorelbine
干预措施: Pyrotinib 320mg + Vinorelbine (Drug)
Pyrotinib plus vinorelbine
干预措施: Pyrotinib 400mg + Vinorelbine (Drug)
Pyrotinib plus vinorelbine
干预措施: Pyrotinib plus Vinorelbine (Drug)
结局指标
主要结局
PFS as Assessed by the Investigator
时间窗: from enrollment to progression or death (for any reason), assessed up to 3 years
Progression-Free Survival
次要结局
- Objective Response Rate(Ratio of CR and PR in all subjects)
- OS(from enrollment to progression or death (for any reason), assessed up to 3 years)
研究者
wang shusen
MD
Sun Yat-sen University