A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ctDNA clearance after one cycle neoadjuvant treatment
研究概览
简要总结
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
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
- 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
- •histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter >2cm)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
- •No prior treatment
排除标准
- •Bilateral or metastatic breast cancer
- •History of other malignancies
- •Severe cardiovascular disease
- •Allergic to any of the regimens
研究组 & 干预措施
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
干预措施: pyrotinib (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
干预措施: pertuzumab (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
干预措施: trastuzumab (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
干预措施: docetaxel (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
干预措施: pertuzumab (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
干预措施: trastuzumab (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
干预措施: docetaxel (Drug)
结局指标
主要结局
ctDNA clearance after one cycle neoadjuvant treatment
时间窗: 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
次要结局
- ctDNA clearance after two cycle neoadjuvant treatment(3 months after neoadjuvant treatment initation)
- pCR rate(6 months after neoadjuvant treatment initation)
- bpCR rate(6 months after neoadjuvant treatment initation)
- ORR(6 months after neoadjuvant treatment initation)
- EFS(2 years after surgery)
- DFS(2 years after surgery)
- OS(5 years after surgery)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine