jRCT2041220123进行中（未招募）不适用
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 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 with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
- •Individuals must have completed treatment for Stage I to 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 for this study.
- •TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
- •Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Demonstrates adequate organ function.
- •Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- •Individuals with 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 prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- •Individuals may not have received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
- •Individuals 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.
- •Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
- •Have an active second malignancy.
- •Have active serious infection requiring antibiotics.
- •Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- •Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- •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 33 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
未报告次要终点
研究者
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