NL-OMON55876已完成3 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 - SYD985.002
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Byondis BV
- 入组人数
- 25
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 至 99（—）
入选标准
- •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
- •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
- •- 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) = 3.0x
- •ULN (or = 5.0x 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.
排除标准
- •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
- •metastases 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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