IRCT20201223049810N1招募中2 期
Evaluation of efficacy and safety of PADYNEX (Trastuzumab-emtansine, T-DM1, manufactured by Nano Daru Pajuhan Pardis) in women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer: A randomised controlled trial, two-arm, open-label.
ano Daru Pajuhan Pardis Company0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- Female
入选标准
- •Women aged 18-75 years
- •Metastatic breast cancer (Metastasis to intraperitoneal solid organs, lungs, pleura, or multiple bones) Based on histological, cytological and imaging results.
- •HER2+ (immunohistochemistry 3+, HER2 gene amplification in fluorescence in situ hybridization positive or positive HER2 result in Chromogenic in situ hybridization).
- •Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors, version 1.1, (the minimum size of a measurable lesion at baseline should be no less than double the slice thickness (when CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness)).
- •Life expectancy of more than 12 weeks based on a physician or treatment team estimate.
- •Acceptable clinical test results at the beginning of the study based on the normal range of the reporting laboratory
- •An Eastern Cooperative Oncology Group performance status of 0–2
- •All the patients provided written informed consent.
排除标准
- •History of type 1 allergic/anaphylactic infusion reactions to any component of the PADYNEX formulation
- •History of treatment with trastuzumab-emtansine
- •Patients with locally advanced breast cancer and non metastatic
- •History of second non-breast cancer in last 5 year
- •Patients with brain metastasis
- •Serious concurrent disease (chronic kidney disease stage 4,5, hepatic impairment child pugh class c, bronchiectasis, severe chronic obstructive pulmonary disease, severe asthma, pulmonary fibrosis)
- •Peripheral neuropathy of grade 3 or worse (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
- •Left ventricular ejection fraction lower than 50% (as measured by echocardiography) within previous 3 months, myocardial infarction or congestive heart failure within previous 6 months, high-risk uncontrolled arrhythmias; clinically significant valvular disease; concomitant medication for the treatment of unstable angina, uncontrolled blood pressure (higher than 200/100 mmHg), severe electrical conduction defect (having a pacemaker or electrocardiogram diagnosis) or Any other significant heart disease.
- •Blood disorders such as baseline absolute neutrophil count lower or equal to 1,500 per microliter or platelet count lower or equal to 100,000 per microliter.
- •Alanine aminotransferase/ aspartate aminotransferase higher or equal to 2.5 upper limit of normal.
- •Pregnancy, breast-feeding, and women of childbearing potential not using contraception.
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