Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Propranolol + Pembrolizumab for Triple Negative Breast Cancer
Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests a drug combination to fight triple negative breast cancer that hasn't responded to previous treatments.
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 belowSelect...
My breast cancer cannot be surgically removed, has spread, and cannot be cured.
Select...
I can swallow and keep down pills.
Select...
I am fully active or can carry out light work.
Select...
I haven't had chemotherapy, radiotherapy, or major surgery in the last 4 weeks.
Select...
I am 18 years old or older.
Select...
My kidneys are functioning well enough for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response
Secondary outcome measures
Incidence of adverse events of propranolol when given in combination with pembrolizumab
Overall survival
Progression free survival
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
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Biopsy
2014
Completed Phase 4
~1090
Propranolol
2010
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
31,082 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
Shipra GandhiPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer cannot be surgically removed, has spread, and cannot be cured.I can swallow and keep down pills.I am fully active or can carry out light work.Your ANC (a type of white blood cell) count is at least 1500 per microliter.Your platelet count is at least 100,000 per microliter.My cancer progressed despite previous treatments including pembrolizumab.My last chemotherapy was over 4 weeks ago, except for pembrolizumab.I cannot take beta-blockers due to health reasons.I haven't had chemotherapy, radiotherapy, or major surgery in the last 4 weeks.Your total bilirubin level should be within the normal range set by the hospital.My cancer did not respond to initial treatment with chemotherapy and pembrolizumab.I haven't taken any immunosuppressive drugs, including steroids, for the last 3 weeks.I have an active autoimmune disease or a history of transplantation.My disease is quickly getting worse and causing symptoms.I am 18 years old or older.I have not had any cancer other than breast cancer in the last 5 years.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I agree to have biopsies before and 6 weeks after starting the treatment.You have a disease that can be measured according to specific guidelines.I have not had brain radiation for new symptoms in the last 4 weeks.Your AST and ALT levels are not more than 2.5 times the normal limit at the testing facility.My kidneys are functioning well enough for treatment.Your hemoglobin level is at least 9.0 grams per deciliter.I am not pregnant or nursing. If capable of bearing children, I will take a pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (propranolol and pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left on this clinical trial?
"Clinicaltrials.gov states that this trial is no longer taking applicants at the time of writing. The study was published on March 1st 2023 and edited for the last time 14th February 2023, however there are 4606 other trials actively recruiting patients right now."
Answered by AI
Has the combination of propranolol and pembrolizumab received regulatory approval?
"Treatment (propranolol and pembrolizumab) is rated a 2 on a safety scale of 1 to 3, as it has only undergone Phase 2 trials. Although the treatment's security has been partially substantiated, there are no reports indicating its efficacy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger