NCT04158856尚未招募2 期
Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors < 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study
xuexin he0 个研究点目标入组 60 人开始时间: 2020年6月1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
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Disease-free Survival
研究概览
简要总结
This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive 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
- •Women aged 18-70 years old
- •Have finished radical operation
- •Histologically confirmed invasive ductal carcinoma (IDCA)
- •According to AJCC ,pT<8mm, pN0, no evidence for metastasis
- •Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2), nuclear grade
- •Should have tumor tissue available and sufficient for multi-spots sampling.
- •It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
- •Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months
- •Cardiac function had to be within normal limits (left ventricular ejection fraction [LVEF] ≥50%), as established by multiple gated acquisition scan or echocardiography.
- •Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
- •Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
- •Written informed consent according to the local ethics committee requirements.
排除标准
- •pT≥8mm or node positive
- •Metastatic breast cancer
- •Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
- •With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- •Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- •Has symptomatic peripheral neuropathy > grade 2 according to NCI
- •Known severe allergy to any drugs in this study
- •Has cardiac dysfunction or lung dysfunction defined as follows:
- •grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
- •angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
- •uncontrolled high-risk arrhythmia
- •uncontrolled hypertension
- •Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
- •Patient is pregnant or breast feeding
研究组 & 干预措施
Experimental Arm
Experimental
adjuvant Pyrotinib plus Trastuzumab
干预措施: Pyrotinib (Drug)
Experimental Arm
Experimental
adjuvant Pyrotinib plus Trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: 5 years
stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.
次要结局
- Breast Cancer Specific Survival(5 years)
- Overall Survival(5 years)
- Treatment-related adverse events(up to 3 months)
- Change of LVEF after treatment(up to 3 months)
研究者
xuexin he
Associate chief physician
Second Affiliated Hospital, School of Medicine, Zhejiang University
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