Evaluating the Efficacy and Safety of Bevacizumab, Carboplatin, Gemcitabine and Atezolizumab in Breast Cancer

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT04739670
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Triple Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab is a monoclonal antibody of IgG1 isotype PD-L1. It is used across a number of tumour types, both as a single-agent and in combination with other therapies such as chemotherapy.
  • Bevacizumab — DRUG
    Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.
  • Gemcitabine — DRUG
    Gemcitabine is a type of chemotherapy drug
  • Carboplatin — DRUG
    Carboplatin is platinum based chemotherapy drug

Study Details

The study hypothesise that the combination of carboplatin, gemcitabine, bevacizumab and atezolizumab may be synergistic and improve outcomes for patients with early relapsed TNBC by overcoming mechanisms of immune resistance and thus potentiating greater and more durable responses to immune checkpoint inhibitor therapy. Early relapsing TNBC represents a high priority, unmet need whereby effective therapeutic strategies are urgently needed.

Key Dates

Start date
Mar 1, 2021
Status verified
Feb 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab, Bevacizumab, Gemcitabine and Carboplatin
    Atezolizumab 1200 mg Day 1 of each 21 day cycle IV, Bevacizumab 15 mg/kg Day 1 of each 21 day cycle IV, Gemcitabine 1000 mg/m2 Day 1 and 8 of each 21 day cycle IV, Carboplatin AUC 5 Day 1 of each 21 day cycle IV

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Assessed after commencement of treatment, until the last registered patient has been followed up for 2 years. ]

Central Contacts