jRCT2041220122进行中（未招募）不适用
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1 (ASCENT-03)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
- 主要终点
- Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- •Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting
- •Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- •Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and >= 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
- •Individuals presenting with de novo metastatic TNBC are eligible
- •Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •as evaluated locally
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Demonstrates adequate organ function
- •Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- •Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- •Positive serum pregnancy test or women who are lactating
- •Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- •Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- •May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- •Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- •Active second malignancy
- •Active serious infection requiring antibiotics
- •Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
时间窗: Randomization up to approximately 22 months
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
次要结局
- Overall Survival (OS)(Randomization up to approximately 57 months)
- Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30)(Randomization up to approximately 57 months)
- Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30(Randomization up to approximately 57 months)
研究者
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