NCT04665986Unknown3 期
A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 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 of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab 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
- 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
- 否
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
NHP
Experimental
Navelbine, Herceptin, Pertuzumab
干预措施: Navelbine (Drug)
THP
Active Comparator
Docetaxel, Herceptin, Pertuzumab
干预措施: Docetaxel (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
- DFS(Following surgery until Year 3)
- 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)
研究者
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