Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
研究概览
简要总结
Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.
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
- 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）
- •HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
- •Primary breast cancer;
- •Known hormone receptor status.
- •The organs are functioning normally, like the liver function, the renal function， and the 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);
- •A history of allergy to the drugs in this study；
- •Unable or unwilling to swallow tablets
研究组 & 干预措施
Pyrotinib, trastuzumab, paclitaxel-albumin
干预措施: Pyrotinib, trastuzumab, paclitaxel-albumin (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
时间窗: Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)
pCR
次要结局
- Objective Response Rate(Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days))
- Event-free survival(Following surgery until year 2)
- minimal residual lesions(Following surgery until year 2)
研究者
Shui Wang
Professor
The First Affiliated Hospital with Nanjing Medical University