NCT03588091已完成3 期
A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
研究概览
简要总结
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •female patients, 18 years ≤ age ≤ 75 years；
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- •HER2 positive (HER2+++ by IHC or FISH+)
- •Known hormone receptor status.
- •Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- •Signed informed consent form (ICF)
排除标准
- •metastatic disease (Stage IV) or inflammatory breast cancer
- •Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- •clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- •Unable or unwilling to swallow tablets.
研究组 & 干预措施
arm1
Experimental
Pyrotinib Plus trastuzumab and docetaxel
干预措施: Pyrotinib (Drug)
arm1
Experimental
Pyrotinib Plus trastuzumab and docetaxel
干预措施: Trastuzumab (Drug)
arm1
Experimental
Pyrotinib Plus trastuzumab and docetaxel
干预措施: Docetaxel (Drug)
arm2
Placebo Comparator
placebo plus trastuzumab and docetaxel
干预措施: Placebo Oral Tablet (Drug)
arm2
Placebo Comparator
placebo plus trastuzumab and docetaxel
干预措施: Trastuzumab (Drug)
arm2
Placebo Comparator
placebo plus trastuzumab and docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
时间窗: through study completion, an average of 1 year
次要结局
- Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites(Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days))
- Event-free survival(EFS)(Following surgery until Year 3)
- Disease-free Survival (DFS)(Following surgery until Year 3)
- Distance Disease-free Survival (DDFS)(Following surgery until Year 3)
- Objective Response Rate (ORR) during neoadjuvant period(Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months)
研究者
研究点 (17)
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