Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

Age >= 18 years of age

Have pathologically confirmed diagnosis of unresectable or metastatic triple negative breast cancer (TNBC) with no curative treatment options

No chemotherapy, radiotherapy, or major surgery within 4 weeks of protocol treatment

Checkpoint inhibitor refractory patients (i.e., no longer responding to chemotherapy and checkpoint inhibitor) who have disease progression on prior line of chemotherapy and pembrolizumab, and, who in the opinion of the physician, can continue checkpoint inhibitor

Disqualifiers

Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment

Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation

Patients with rapidly progressive disease/ symptomatic disease

Patients with primary resistance (i.e., did not respond to initial treatment with chemotherapy plus checkpoint inhibitor) with progressive disease at 12 weeks after starting chemotherapy and pembrolizumab

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Pembrolizumab
  • Propranolol
  • Questionnaire Administration

Treatment groups

37 Participants
are divided into 1 treatment group

Locations

2
Emory University Hospital30322, AtlantaGeorgia, United States
Roswell Park Cancer Institute14263, BuffaloNew York, United States

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator