Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer
This phase II trial tests how well propranolol and pembrolizumab work to cause tumor re-sensitization and therefore treatment in patients with triple negative breast cancer that has not responded to previous checkpoint inhibitor therapy (refractory), cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Propranolol is a drug that is classified as a beta-blocker. Beta-blockers affect the heart and circulation. Beta-blockers, like propranolol, may help to counteract effects of certain stress hormones produced by the body during cancer treatment and may increase the effectiveness of the pembrolizumab. Pembrolizumab is a drug that is classified as an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Propranolol may be able to re-sensitize the cells of the immune system to respond to the checkpoint inhibitor pembrolizumab in patients with checkpoint inhibitor refractory metastatic or unresectable triple negative breast cancer.
PRIMARY OBJECTIVE: I. Determine the efficacy of propranolol on tumor re-sensitization, when given in combination with pembrolizumab in patients with checkpoint inhibitor refractory metastatic triple negative breast cancer. SECONDARY OBJECTIVES: I. Assess 6-month progression-free and overall survival per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). II. Safety and tolerability of propranolol when given in combination with pembrolizumab. EXPLORATORY OBJECTIVES: I. Assess changes in immune markers (pre-treatment versus [vs] post-treatment) in biopsy and peripheral blood. II. Correlate perceived stress scale with immune exhaustion markers and immune cells in the peripheral blood and tumor. OUTLINE: Patients receive propranolol orally (PO) and pembrolizumab intravenously (IV) while on study. Patients undergo computed tomography (CT) scan, blood sample collection and may undergo tumor biopsy during screening and on study. ;
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