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A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

NCT03498716 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2199

Last updated 2024-08-21

Study results available
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Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Conditions

Interventions

DRUG

Atezolizumab

Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year

DRUG

Paclitaxel

Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.

DRUG

Dose-dense Doxorubicin or dose-dense Epirubicin

Dose-dense doxorubicin will be administered by IV, 60 mg/m\^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m\^2) every 2 weeks for a total of 4 doses

DRUG

Cyclophosphamide

Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • Alliance Foundation Trials, LLC.

    collaborator OTHER

  • Jules Bordet Institute

    collaborator OTHER

  • Frontier Science & Technology Research Foundation, Inc.

    collaborator INDUSTRY

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2023-08-14
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03498716 on ClinicalTrials.gov