NCT04922008尚未招募2 期
An Open-label, Phase II Study Evaluating the Efficacy and Safety of Trastuzumab Combined With Oral Chemotherapy in Patients With HER-2 Positive Stage I Breast Cancer
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
- 入组人数
- 356
- 主要终点
- iDFS
研究概览
简要总结
This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy (capecitabine or vinorelbine) in patients with HER-2 positive stage I breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Females 18-70 years old;
- •Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the lymph node is negative (N0);
- •If a patient is HR negative(ER/PR<10%), the longest diameter of invasive cancer could not exceed 2cm; while if a patient is HR positive(ER and/or PR ≥10%）,the longest diameter of invasive cancer is greater than 1cm and no more than 2cm;
- •The pathological type of immunohistochemistry must meet the following conditions: HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;
- •For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled;
- •Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST)
- •≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);
- •LVEF>50%;
- •The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
排除标准
- •Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;
- •Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;
- •Has metastic (Stage 4) breast cancer;
- •Pregnant or breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
- •Patients participating in other clinical trials at the same time;
- •Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- •Has severe or uncontrolled infection;
- •Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
- •The researchers considered patients to be unsuitable for the study.
研究组 & 干预措施
IRIS-C
Experimental
干预措施: capecitabine and trastuzumab (Drug)
IRIS-D
Experimental
干预措施: vinorelbine and trastuzumab (Drug)
结局指标
主要结局
iDFS
时间窗: 5 years
iDFS invasive disease-free survival
次要结局
- DDFS(5 years)
- OS(5 years)
研究者
相似试验
进行中（未招募）
2 期
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)Breast CancerNCT04383275Fudan University367
已完成
2 期
Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOXMetastatic or Recurrent Gastric AdenocarcinomaHer-2 Positive Gastric CancerNCT01396707Asan Medical Center55
Unknown
2 期
Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast CancerHER-2 Positive Breast CancerNCT01428414Zhimin Shao100
招募中
2 期
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast CancerEarly-stage Breast CancerHormone Receptor Positive Breast CarcinomaStage II Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage III Breast CancerInvasive Breast CancerNCT04553770Jonsson Comprehensive Cancer Center88
Unknown
2 期
Evaluation of Trastuzumab in Combination With Lapatinib or Pertuzumab in Combination With Trastuzumab-Emtansine to Treat Patients With HER2-positive Metastatic Colorectal CancerMetastatic Colorectal CancerNCT03225937Fondazione del Piemonte per l'Oncologia54