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A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants 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

NCT02425891•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
•No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
•Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
•A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
•Eastern Cooperative Oncology Group performance status of 0 or 1
•Measurable disease as defined by RECIST v1.1
•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 human immunodeficiency virus
•Active hepatitis B or hepatitis C
•Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo

Locations (247)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Kaiser Permanente of Northern California

Oakland, California, United States

Emad Ibrahim, Md, Inc

Redlands, California, United States

Univ of Calif, San Francisco; Breast Cancer Center

San Francisco, California, United States

Kaiser Permanente - San Marcos

San Marcos, California, United States

Cancer Research Collaboration, Inc.

Santa Ana, California, United States

Stanford Univ School of Med; Oncology

Stanford, California, United States

Kaiser Permanente Of Colorado

Aurora, Colorado, United States

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, United States

Key Dates

Start Date

June 23, 2015

Primary Completion Date

April 14, 2020

Completion Date

August 31, 2021

Last Updated

July 19, 2022

Enrollment

902

ACTUAL participants

Conditions

Triple Negative Breast Cancer

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

DRUG

Nab-Paclitaxel

DRUG

Placebo

DRUG

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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RECRUITINGPHASE1

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NCT07029399

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

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