A PHASE III MULTICENTER,RANDOMIZED,PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB(ANTI-PD-L1 ANTIBODY)IN COMBINATION WITH NAB-PACLITAXEL COMPARED WITH PLACEBO WITH NAB-PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC TRIPLE-NEGATIVE BREAST CANCER

CHUGAI PHARMACEUTICAL CO., LTD.0 个研究点目标入组 902 人开始时间: 2016年6月2日最近更新: 2023年10月17日

试验速览

阶段: 3 期
状态: 已完成
发起方: CHUGAI PHARMACEUTICAL CO., LTD.
入组人数: 902

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patients with metastatic triple-negative breast cancer in both the intention-to-treat population and the PD-L1-positive subgroup. Adverse events were consistent with the known safety profiles of each agent.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•Metastatic or locally advanced, histologically documented Triple-Negative Breast Cancer (TNBC)
•-No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
•-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•-Measurable disease
•-Adequate hematologic and end-organ function

排除标准

•-Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
•-Leptomeningeal disease
•-Pregnancy or lactation
•-History of autoimmune disease
•-Prior allogeneic stem cell or solid organ transplantation
•-Positive test for HIV
•-Active hepatitis B or hepatitis C

研究者

发起方

CHUGAI PHARMACEUTICAL CO., LTD.

相似试验

已完成

3 期

A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-paclitaxel Compared With Carboplatin + Nab-paclitaxel in Patients With Stage IV Squamous NSCLCon-Small Cell Lung Cancer

JPRN-jRCT2080222847Chugai Pharmaceutical Co., Ltd.1,021

已完成

3 期

A Comparative Study of atezolizumab(MPDL3280A)With standard chemotherapy in Patients With Stage IV NSCLCon-Small Cell Lung Cancer

JPRN-jRCT2080222849Chugai Pharmaceutical Co., Ltd.572

已完成

3 期

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial CarcinomaUrothelial Carcinoma

NCT02807636Hoffmann-La Roche1,213

已完成

3 期

A Phase III Study of atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer [IMpower132]

JPRN-jRCT2080223142CHUGAI PHARMACEUTICAL CO., LTD.578

已完成

3 期

A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Canceron-Small Cell Lung Cancer

JPRN-jRCT2080222890CHUGAI PHARMACEUTICAL CO., LTD1,202