Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple-negative Breast Cancer

Summary

This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide are the Investigational Medicinal Products (IMPs).

Conditions

• Cancer, Breast
• Triple Negative Breast Cancer

Interventions

DRUG

Atezolizumab

Atezolizumab is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, Atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

DRUG

Pegylated liposomal doxorubicin

Chemotherapy

DRUG

Cyclophosphamide

Chemotherapy

OTHER

Placebo

Placebo

Sponsors & Collaborators

• Hoffmann-La Roche

  collaborator INDUSTRY

• Norwegian Cancer Society

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Rigshospitalet, Denmark

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• NanoString Technologies, Inc.

  collaborator INDUSTRY

• Technical University of Denmark

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Jon Amund Kyte, M.D.-Ph.D. · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2023-04-25

Completion

2023-09-30

Countries

• Denmark
• Norway

Study Locations