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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

NCT03197935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2023-10-26

Study results available
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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).

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Atezolizumab was administered as per schedule described in respective arm.

DRUG

Placebo

Placebo matched to atezolizumab was administered as per schedule described in respective arm.

DRUG

Nab-paclitaxel

Nab-paclitaxel was administered as per schedule described in the arms.

DRUG

Doxorubicin

Doxorubicin was administered as per schedule described in the arms.

DRUG

Cyclophosphamide

Cyclophosphamide was administered as per schedule described in the arms.

DRUG

Filgrastim

Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

DRUG

Pegfilgrastim

Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2020-04-03
Completion
2022-09-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Germany
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197935 on ClinicalTrials.gov