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Checkpoint Inhibitor

Propranolol + Pembrolizumab for Triple Negative Breast Cancer

Buffalo, NY

Phase 2

Recruiting

Led By Shipra Gandhi

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Ability to swallow and retain oral medication

Must not have

Contraindications to the use of beta-blockers

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug combination to fight triple negative breast cancer that hasn't responded to previous treatments.

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Who is the study for?

This trial is for adults with triple negative breast cancer that's spread, can't be surgically removed, or hasn't responded to checkpoint inhibitor therapy. Participants must have finished any major treatments at least 4 weeks prior and agree to biopsies. They should not have other cancers within the last 5 years, uncontrolled illnesses, or be on immunosuppressives.Check my eligibility

What is being tested?

The trial tests propranolol (a beta-blocker) combined with pembrolizumab (an immune checkpoint inhibitor) in patients whose cancer didn't respond to previous therapies. The goal is to see if propranolol can make the immune system react better to pembrolizumab.See study design

What are the potential side effects?

Possible side effects include those common to beta-blockers like fatigue, dizziness, and heart-related issues; and for pembrolizumab: immune reactions affecting organs, infusion-related symptoms, skin rash, itching and flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer cannot be surgically removed, has spread, and cannot be cured.

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I can swallow and keep down pills.

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I am fully active or can carry out light work.

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I haven't had chemotherapy, radiotherapy, or major surgery in the last 4 weeks.

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I am 18 years old or older.

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My kidneys are functioning well enough for treatment.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take beta-blockers due to health reasons.

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I have an active autoimmune disease or a history of transplantation.

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My disease is quickly getting worse and causing symptoms.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have not had brain radiation for new symptoms in the last 4 weeks.

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I am not pregnant or nursing. If capable of bearing children, I will take a pregnancy test.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response

Secondary study objectives

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

Overall survival

Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (propranolol and pembrolizumab)Experimental Treatment6 Interventions

Patients receive propranolol PO and pembrolizumab IV while on study. Patients undergo CT scan, blood sample collection and may undergo tumor biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1210

Biospecimen Collection

2004

Completed Phase 3

~1810