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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223227

Enrollment

900

Registered

2016-06-02

Start date

2016-08-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple negative breast cancer

Interventions

investigational material(s) Generic name etc : atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Progression-free survival, Overall survival RECIST v1.1, Obserbation	—

Secondary

Measure	Time frame
safety efficacy exploratory pharmacokinetics Objective response rate,Safety RECIST v1.1,Obserbation	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026