Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Early Stage or Locally Advanced Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- ORR
研究概览
简要总结
This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2 positive early stage or locally advanced breast cancer.
详细描述
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Vinorelbine 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
- 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
- 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-
- •Histologically confirmed invasive breast cancer:early stage or locally advanced,Primary tumour greater than 2 cm diameter
- •HER2 positive (HER2+++ by IHC or FISH+)
- •Subjects received neoadjuvant therapy with trastuzumab 2 weeks post-imaging evaluation Patients with a price of PD or SD.
- •Known hormone receptor status.
- •Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- •Signed the informed consent form prior to patient entry.
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 +Vinorelbine
Pyrotinib in Combination With Trastuzumab Plus Vinorelbine
干预措施: Pyrotinib and Trastuzumab plus Vinorelbine (Drug)
结局指标
主要结局
ORR
时间窗: [Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Objective Response Rate
次要结局
- Pathological Complete Response (pCR)(Time Frame: through study completion, an average of 1 year)
- EFS(Time Frame: Following surgery until Year 5)
- DFS(Time Frame: Following surgery until Year 5)
- DDFS(Time Frame: Following surgery until Year 5)