A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 48
- 主要终点
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
研究概览
简要总结
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
详细描述
This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2) -positive unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes. Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
- •Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
- •Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or
- •Presence of at least one measurable lesion according to RECIST v1.1
- •Expected survival time ≥ 12 weeks.
- •Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study.
排除标准
- •Prior anti-HER2 ADC therapy.
- •Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
- •Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
- •Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
- •Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
- •Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
DB-1303/BNT323
Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
干预措施: DB-1303/BNT323 (Drug)
T-DM1
Enrolled patients will receive T-DM1 by I.V. infusion
干预措施: T-DM1 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: Up to approximately 24 months.
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first
次要结局
- Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1(Up to approximately 24 months.)
- PK parameters: maximum observed concentration (Cmax)(Up to approximately 24 months.)
- Overall Survival (OS)(Up to approximately 24 months.)
- Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1(Up to approximately 24 months.)
- Adverse events (AEs)(Up to approximately 24 months.)
- Patient reported outcomes (PROs): EORTC QLQ-BR45(Up to approximately 24 months.)
- Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1(Up to approximately 24 months.)
- PK parameters: time to maximum concentration (Tmax)(Up to approximately 24 months.)
- Anti-drug antibodies (ADA)(Up to approximately 24 months.)
- Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30(Up to approximately 24 months.)
- Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)(Up to approximately 24 months.)
- European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)(Up to approximately 24 months.)