NCT05165225进行中（未招募）2 期
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年7月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Residual cancer burden 0/1 (RCB-0/1) rate
研究概览
简要总结
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR positive and HER2-low-expressing early 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
- •Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures
- •Female patients, age ≥ 18 years
- •Histologically confirmed unilateral primary carcinoma of the breast, except for occult breast cancer, inflammatory breast cancer without assessable focus or eczema like breast cancer
- •HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/or PR >1% stained cells)
- •Tumour greater than 2 cm diameter or histologically (core- or fine-needle biopsy) involved lymph nodes
- •According to RECIST version 1.1, there is at least one evaluable target lesion
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Required laboratory values including following parameters: WBC count:≥3.0 x 10^9/L ; 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: ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine: ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 55%
- •For female patients without menopause or surgical sterilization: consent to contraception both during the trial and within 6 months after the last administration of the test drug
排除标准
- •Metastatic disease (Stage IV) or bilateral breast cancer
- •Known history of hypersensitivity to pyrotinib or any of it components
- •According to the judgment of the researcher, other anti-tumor treatments (except for ovarian function inhibitors) are required during neoadjuvant therapy
- •Patients with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to these: 1). Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 atrioventricular block or third degree atrioventricular block) 2). Unstable angina pectoris 3). Heart valve disease with clinical significance 4). ECG showed transmural myocardial infarction pain 5). Poor control of hypertension
- •Patients underwent major breast cancer-free surgery within 4 weeks or have not fully recovered
- •Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc
- •History of other malignant tumors in the past 5 years (excluding cured carcinoma in situ of cervix or skin basal cell carcinoma)
- •Those with basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation)；Inability to swallow、intestinal obstruction or other factors will affect drug administration and absorption
- •The investigator believes that the patient has any other conditions that are not suitable for participation in the study
研究组 & 干预措施
Pyrotinib
Experimental
Experimental: Patients will receive Pyrotinib combined with Epirubicin and Cyclophosphamide followed by Docetaxel
干预措施: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment (Drug)
结局指标
主要结局
Residual cancer burden 0/1 (RCB-0/1) rate
时间窗: within 6 weeks after surgery
The percentage of patients with RCB-0/1 after neoadjuvant therapy
次要结局
- Incidence of grade 3-5 diarrhea.(before surgery)
- Pathological complete response (pCR) rate(within 6 weeks after surgery)
- Biomarkers(5 years)
- Objective response rate (ORR)(within 6 weeks after surgery)
- Breast conservation rate.(within 6 weeks after surgery)
- Disease-free Survival (DFS)(5 years)
- Overall Survival (OS).(5 years)
研究者
Chang Gong
Chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.HER2 Positive Breast CancerNCT03947242Henan Cancer Hospital48
尚未招募
不适用
Pyrotinib in HER2-positive Early Breast CancerHER2-positive Breast CancerNCT06718335Nie Jianyun156
招募中
2 期
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT05104788Peking University Cancer Hospital & Institute27
Unknown
不适用
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast CancerNeoplasm, BreastBreast DiseasesBreast CancerNCT03756064Zhejiang Cancer Hospital100
招募中
2 期
Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial TumorThymic Epithelial TumorNCT04667793Shanghai Pulmonary Hospital, Shanghai, China15