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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Byondis B.V.
- 入组人数
- 437
- 试验地点
- 89
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
详细描述
This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The 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.
Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
- •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;
- •HER2-positive tumor status;
- •Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •Estimated life expectancy > 12 weeks at randomization;
- •Adequate organ function and blood cell counts.
排除标准
- •Current or previous use of a prohibited medication as listed in the protocol;
- •History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;
- •History of keratitis;
- •Severe, uncontrolled systemic disease at screening;
- •Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
- •Cardiac troponin value above the Upper Limit of Normal (ULN);
- •History of clinically significant cardiovascular disease;
- •Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
- •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.
研究组 & 干预措施
(vic-)trastuzumab duocarmazine
SYD985, every 3 weeks (Q3W)
干预措施: (vic-)trastuzumab duocarmazine (Drug)
Physician's choice
- Lap/Cap
- T/Cap
- T/Vino
- T/Eri
干预措施: Physician's choice (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: baseline until primary analysis data cut-off date of 31March2021
Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.
次要结局
- Investigator Assessed Progression Free Survival(baseline until primary analysis data cut-off date of 31March2021)
- Patient Reported Outcomes for Health Related Quality of Life(baseline until primary analysis data cut-off date of 31March2021)
- Overall Survival(baseline until final Overall Survival analysis data cut-off date of 30June2022)
- Objective Response Rate(baseline until primary analysis data cut-off date of 31March2021)