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

ConditionsAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaRefractory Triple-Negative Breast CarcinomaUnresectable Triple-Negative Breast Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Propranolol

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Treatment (propranolol and pembrolizumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Objective response

Efficacy as determined by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Will be summarized using frequencies and relative frequencies. The best response within the first 6 months will be determined as the best objective response.

Time frame
Up to 6 months

Secondary outcomes

1

Progression free survival

This will be summarized using standard Kaplan-Meier methods with 90% confidence intervals obtained for the median and 6-month rates.

Time frame
The time treatment initiation until disease progression (per irRECIST), death due to any cause, subsequent therapies (treated as censored), or last follow-up, assessed up to 6 months
2

Overall survival

Measured per irRECIST. This will be summarized using standard Kaplan-Meier methods with 90% confidence intervals obtained for the median and 6-month rates.

Time frame
The time from treatment initiation until death due to any cause or last follow-up, assessed up to 6 months
3

Incidence of adverse events of propranolol when given in combination with pembrolizumab

Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by attribution and grade using frequencies and relative frequencies.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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