A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 268
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR)
研究概览
简要总结
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
详细描述
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.
It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy.
The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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）
- •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
Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
干预措施: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR)
时间窗: through study completion, an average of 1 year
次要结局
- Event-free survival(Following surgery until Year 3)
- Disease-free Survival(Following surgery until Year 3)
- Distance Disease-free Survival(Following surgery until Year 3)
- Objective Response Rate(Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months)
研究者
Yu-Zhi Gang
Director
The Second Hospital of Shandong University