NCT07673029招募中3 期
A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 70
- 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 GQ1005 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 phase III, multicenter, open-label, randomized controlled study comparing GQ1005 with Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane. Approximately 228 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive GQ1005 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 75 Years（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 NOTE: Other protocol defined Inclusion/
排除标准
- •Exclusion Criteria:
- •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.
研究组 & 干预措施
T-DM1
Experimental
T-DM1 will be administered intravenously every 21 days.
干预措施: T-DM1 (Drug)
GQ1005
Experimental
GQ1005 will be administered intravenously every 21 days.
干预措施: GQ1005 (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
次要结局
- Overall Survival (OS)(Up to approximately 24 months)
- Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1(Up to approximately 24 months)
- Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1(Up to approximately 24 months)
- Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1(Up to approximately 24 months)
- Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1(Up to approximately 24 months)
- Adverse events：Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the Nationa(Up to approximately 24 months)
- PK parameters：Plasma concentrations of GQ1005 ADC, total anti-HER2 antibody and free toxin DXd at each time point(Up to approximately 24 months)
- Anti-drug antibodies (ADA)：Number and percentage of patients who develop anti-drug antibody (ADA).(Up to approximately 24 months)
- Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EQ-5D-5L(Up to approximately 24 months)
- Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30(Up to approximately 24 months)
- Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EORTC QLQ-BR45(Up to approximately 24 months)
研究者
研究点 (70)
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