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

Sponsor
Oslo University Hospital
Study ID
NCT03164993
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.
  • Pegylated liposomal doxorubicin — DRUG
    Chemotherapy
  • Cyclophosphamide — DRUG
    Chemotherapy
  • Placebo — OTHER
    Placebo

Study Details

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).

Key Dates

Start date
Jun 1, 2017
Status verified
Oct 2023
Primary completion
Apr 25, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm Chemotherapy + Placebo
    Chemo (pegylated liposomal doxorubicin + cyclophosphamide) + placebo
  • Active Comparator: Arm Chemotherapy + Atezolizumab
    Chemo (pegylated liposomal doxorubicin + cyclophosphamide) + Atezolizumab

Primary Outcome Measure

Assessment of toxicity of combined treatment with Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide [ Time Frame: From inclusion until last follow-up visit (12 weeks after end of treatment if progressive disease; 12 months after end of treatment if no disease progression) ]

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