Metastatic Breast Cancer Clinical Trial
Official title:
Abrogation of Chronic Monoclonal Antibody Treatment-induced T-cell Exhaustion With DURVALUMAB (MEDI4736) in Advanced HER-2 Negative Breast Cancer: a Pilot Proof-of-concept Trial
This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects
will be enrolled in 6 sites.
Metastatic breast cancer patients with disease progression to bevacizumab maintenance
treatment will be potential candidates.
Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in
monotherapy, with hormonal treatment or combined with chemotherapy in the context of previous
bevacizumab plus chemotherapy regimens.
When progression to bevacizumab maintenance treatment occurs, patients will enter the trial
and will start receiving DURVALUMAB 10 mg/kg Q2W IV infusion plus bevacizumab 10mg/kg IV
infusion every 2 weeks. The patients will undergo a tumor biopsy before the first dose of
DURVALUMAB, and after one month of combined treatment - the blood sampling will continue on a
monthly basis. The treatment will continue until disease progression.
Acquired resistance against chronic administration of the monoclonal antibody antiangiogenic agent like bevacizumab in breast cancer is caused in a fraction of patients by an immune reprogramming. The immune reprogramming can be detected by elevated counts of Tregs in peripheral blood, aberrant pattern of cytokines, and elevated concentrations of kynurenine and immunosuppressive/vasodilator prostaglandins. The addition of DURVALUMAB to a bevacizumab-based treatment would delay or abrogate these changes and be of therapeutic interest in this scenario. ;
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