EUCTR2017-001994-18-BE进行中（未招募）1 期
A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibody-drug conjugate SYD985 to physician’s choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Byondis BV
- 入组人数
- 345
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Any patient must meet the following inclusion criteria:
- •1. Female patients, age = 18 years old at the time of signing informed consent;
- •2. Patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
- •3. Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;
- •4. HER2-positive tumour status according to the ASCO-CAP guidelines (defined as a 3+ score on immunohistochemistry (IHC) and/or positive by in situ hybridization (ISH)) confirmed by the central laboratory;
- •5. Patients must have measurable or non-measurable disease that is evaluable per Response Evaluation Criteria for Solid Tumours (RECIST version 1.1). Patients with bone-only sclerotic disease without a lytic component are not eligible;
- •6. Eastern Cooperative Oncology Group (ECOG) performance status = 2;
- •7. Estimated life expectancy > 12 weeks at randomization;
- •8. Adequate organ function, evidenced by the following (local) laboratory results:
- •–Absolute neutrophil count = 1.5 x 109/L;
- •–Platelet count = 100 x 109/L;
- •–Hemoglobin = 9.0 g/dL;
- •–Total bilirubin = 1.5 x the upper limit of normal (ULN);
- •–Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 x ULN (or = 5.0 x ULN in the presence of liver metastases);
- •–Serum creatinine = 1.5 x ULN;
- •9. For women of childbearing potential two methods of effective contraception must be used during the study and up to 6 months after last study treatment. This is not required in case the patient or sole partner is surgically sterilized or in case the patient truly abstains from sexual activity.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 258
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •Any patient who meets any of the exclusion criteria below must be excluded from participation in the study:
- •1. Having been treated with:
- •a. SYD985 at any time;
- •b. Anthracycline treatment within 12 weeks prior to randomization;
- •c. Other anticancer therapy including chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to randomization;
- •d. Radiotherapy within 2 weeks prior to randomization;
- •e. Hormone therapy within 1 week prior to randomization;
- •The patient must have sufficiently recovered from any treatment-related toxicities to NCI CTCAE Grade = 1 (except for toxicities not considered a safety risk for the patient at the investigator’s discretion);
- •2. History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine or excipients of the study drug which led to permanent discontinuation of the treatment;
- •3. History of keratitis;
- •4. Severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) at screening;
- •5. Left ventricular ejection fraction (LVEF) < 50% as assessed by either echocardiography or multigated acquisition (MUGA) scan at screening, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine leading to permanent discontinuation of treatment;
- •6. Cardiac troponin value above the ULN (local laboratory) at screening;
- •7. History (within 6 months prior to randomization) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
- •8. Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization. Patients with prior treatment of brain metastasis must have evidence of disease stability on baseline brain imaging as compared to historical brain imaging;
- •9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
- •10. Known active Hepatitis B or C infection;
- •11. Major surgery within 4 weeks prior to randomization;
- •12. Pregnancy or lactation;
- •13. Other condition, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.
研究者
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