Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Invasive Disease-free Survival (iDFS) at year 2
研究概览
简要总结
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.
However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
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
- •Subjects voluntarily participate in this study and sign the informed consent form；
- •Female or male patients, aged ≥ 18 years, and ≤75 years;
- •ECOG PS score: 0-1;
- •Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
- •Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
- •Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM
- •Could have been treated neoadjuvantly but have not reached pathologic complete response.
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
- •History of gastrointestinal disease with diarrhea as the major symptom.
研究组 & 干预措施
Pyrotinib
pyrotinib 400mg orally daily for one year
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Invasive Disease-free Survival (iDFS) at year 2
时间窗: From enrollment until time of events up to 2 years
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
次要结局
- Invasive Disease-free Survival (iDFS) at year 5(From enrollment until time of events up to 5 years)
- AEs and SAEs(From the first administration to one months after the last drug administration)
- Disease-free Survival at year 2 (2y-DFS)(From enrollment until time of events up to 2 years)
- Overall Survival (OS)(Enrollment until death due to any cause, up to 10 years)
研究者
Liu Xiaoan
Professor
The First Affiliated Hospital with Nanjing Medical University