jRCT2031240476招募中不适用
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 77
- 主要终点
- Progression free survival (PFS)
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
- •Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- •Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- •Is a chemotherapy candidate
- •Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- •Has adequate organ function
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- •Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has breast cancer amenable to treatment with curative intent
- •Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- •Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- •Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- •Active autoimmune disease that has required systemic treatment in the past 2 years
- •History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- •Has an active infection requiring systemic therapy
结局指标
主要结局
Progression free survival (PFS)
The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)
- Objective Response (OR)
- Duration of Response (DOR)
- Change from baseline in EORTC QLQ-C30
- Time to first deterioration (TTD)
研究者
相似试验
进行中（未招募）
1 期
Evaluation of efficacity and safety of pembrolizumabEUCTR2016-002076-28-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)39
已完成
2 期
A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancerbladder cancerurothelial cancer10038364NL-OMON46877Merck Sharp & Dohme (MSD)5
进行中（未招募）
1 期
A Phase II Study of Pembrolizumab in Subjects with Triple-Negative Breast CancerTriple-Negative Breast CancerEUCTR2015-000294-13-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.254
进行中（未招募）
1 期
A Phase II Trial of MK-3475 in Subjects with Bladder Canceradvanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.MedDRA version: 17.1Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864EUCTR2014-002206-20-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.350
进行中（未招募）
1 期
A Phase II Study of Pembrolizumab in Subjects with Triple-Negative Breast CancerTriple-Negative Breast CancerEUCTR2015-000294-13-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.170