Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer: a Single-arm, Ahead, Open-label Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given 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 (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.
It is proposed that 100 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T1-4N0-3M0) 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients, 18 years ≤ age ≤ 80 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
Experimental group
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
干预措施: Pyrotinib (Drug)
Experimental group
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
干预措施: Trastuzumab (Drug)
Experimental group
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
干预措施: Docetaxel (Drug)
Experimental group
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
干预措施: Carboplatin (Drug)
Control group
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
干预措施: Trastuzumab (Drug)
Control group
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
干预措施: Docetaxel (Drug)
Control group
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
干预措施: Carboplatin (Drug)
Control group
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
pCR
时间窗: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
次要结局
- DDFS(Following surgery until Year 3)
- ORR(Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months)
- EFS(Following surgery until Year 3)
- DFS(Following surgery until Year 3)