A Phase III Study of atezolizumab or Placebo in Combination With Nab-paclitaxel For Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer[IMpassion130]

Phase 3

Completed

• Conditions: Triple negative breast cancer

• Registration Number: JPRN-jRCT2080223227
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-02
• Results First Posted: 2018-10-20
• Study Completion: 2020-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 902

Inclusion Criteria

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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>confirmatory<br>Progression-free survival, Overall survival<br><br>RECIST v1.1, Obserbation

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>Objective response rate,Safety<br><br>RECIST v1.1,Obserbation