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A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

NCT03125902•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PR\] expression), not amenable to surgical therapy
•Participants eligible for taxane monotherapy
•No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
•Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 17 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.
•Eastern Cooperative Oncology Group performance status of 0 or 1
•Life expectancy at least 12 weeks
•Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end-organ function
•Negative human immunodeficiency virus (HIV) test at screening.
•Negative hepatitis B surface antigen (HBsAg) test at screening
+4 more criteria

Exclusion Criteria

•Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization
•Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
•Leptomeningeal disease
•Uncontrolled pleural effusion, pericardial effusion, or ascites
•Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
•Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
•Pregnant or breast-feeding women, or intending to become pregnant during the study
•Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
•Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
•Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis
+2 more criteria

Locations (161)

Stanford Cancer Center

Stanford, California, United States

Florida Cancer Specialists; Department of Oncology

Fort Myers, Florida, United States

Florida Cancer Specialist, North Region

St. Petersburg, Florida, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

HCA Midwest Health

Kansas City, Missouri, United States

The Valley Hospital

Paramus, New Jersey, United States

Magee-Woman's Hospital

Pittsburgh, Pennsylvania, United States

Tennessee Oncology; Sarah Cannon Research Institute

Nashville, Tennessee, United States

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Centro de Pesquisas Clinicas em Oncologia - CPCO

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Key Dates

Start Date

August 25, 2017

Primary Completion Date

November 15, 2019

Completion Date

January 17, 2023

Last Updated

March 26, 2024

Enrollment

653

ACTUAL participants

Conditions

Triple-Negative Breast Cancer

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

DRUG

Atezolizumab Placebo

DRUG

Paclitaxel

DRUG

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

NCT05806060

Triple-Negative Breast Cancer

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RECRUITING

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

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RECRUITINGNA

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

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: March 26, 2024Data 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 and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Inclusion Criteria

Exclusion Criteria

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Reverse Triple Negative Immune Resistant Breast Cancer

Study of AVZO-021 in Patients With Advanced Solid Tumors

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia