Pre-operative Immunotherapy Combination Strategies in Breast Cancer

Sponsor
Queen Mary University of London
Study ID
NCT03395899
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    PD-L1 antibody
  • Cobimetinib — DRUG
    Highly selective small-molecule inhibitor of MEK1 and MEK2
  • Ipatasertib — DRUG
    Selective, ATP-competitive small molecule inhibitor of all three isoforms of the serine/threonine kinase Akt
  • Bevacizumab — DRUG
    Highly specific humanized monoclonal antibody that targets VEGF

Study Details

International, open label, window of opportunity phase II trial that aims to evaluate the effects of immunotherapy based treatment combinations in women with untreated, histologically confirmed, operable, ER+, HER2-negative breast cancer.

Key Dates

Start date
Dec 21, 2017
Status verified
Jun 2024
Primary completion
Aug 18, 2023
Completion
Aug 18, 2023

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Atezolizumab alone
    1200mg of Atezolizumab D1 C1
  • Experimental: Atezolizumab + Cobimetinib
    Atezolizumab (1200mg IV D1 C1) + Cobimetinib (60mg PO D1 - 21 of C1)
  • Experimental: Atezolizumab + Ipatasertib
    Atezolizumab (1200mg IV D1 C1)+ Ipatasertib (400mg OD D1 - 21 of C1)
  • Experimental: Atezolizumab + Ipatasertib + Bevacizumab
    Atezolizumab (1200mg IV D1 C1)+ Cobimetinib (60mg PO D1 - 21 of C1) + Bevacizumab (10mg/kg IV D1 C1)

Primary Outcome Measure

2-fold Increase in GzmB+ CD8+ T cell levels [ Time Frame: Baseline and at 3weeks ]

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