Loading clinical trials...

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer

NCT03197935•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status)
•Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen
•Primary breast tumor size of greater than (\>) 2 centimeters (cm) by at least one radiographic or clinical measurement
•Stage at presentation: cT2-cT4, cN0-cN3, cM0
•Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
•Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
•Adequate hematologic and end-organ function
•Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
+2 more criteria

Exclusion Criteria

•Prior history of invasive breast cancer
•Stage 4 (metastatic) breast cancer
•Prior systemic therapy for treatment and prevention of breast cancer
•Previous therapy with anthracyclines or taxanes for any malignancy
•History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy \>5 years prior to diagnosis of current breast cancer
•History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed \>5 years prior to diagnosis of current breast cancer
•Bilateral breast cancer
•Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
•Axillary lymph node dissection prior to initiation of neoadjuvant therapy
•History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
+20 more criteria

Locations (68)

Stanford University Medical Center

Palo Alto, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, United States

Mercy Medical Center

Baltimore, Maryland, United States

HCA Midwest Division

Kansas City, Missouri, United States

The Valley Hospital; Valley Medical Group

Paramus, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Key Dates

Start Date

July 24, 2017

Primary Completion Date

April 3, 2020

Completion Date

September 28, 2022

Last Updated

October 26, 2023

Enrollment

333

ACTUAL participants

Conditions

Triple-negative Breast Cancer

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

DRUG

Placebo

DRUG

Nab-paclitaxel

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Filgrastim

DRUG

Pegfilgrastim

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

View study

RECRUITING

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

NCT05914961

TNBC - Triple-Negative Breast Cancer

View study

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: October 26, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

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