Study on Propranolol and Pembrolizumab for Treating Advanced Triple Negative Breast Cancer
Sponsor: Roswell Park Cancer Institute
ClinicalTrials ID:NCT05741164
This clinical trial is exploring whether a combination of propranolol and pembrolizumab can help treat patients with advanced triple negative breast cancer that has not responded to previous treatments. The study aims to see if propranolol can make the cancer more responsive to pembrolizumab, an immunotherapy drug.
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Program Overview
This phase II study is testing how well the combination of propranolol, a beta-blocker, and pembrolizumab, an immune checkpoint inhibitor, works in patients with triple negative breast cancer that has not responded to previous treatments, cannot be removed by surgery, or has spread to other parts of the body. Propranolol may help the immune system respond better to pembrolizumab by counteracting stress hormones produced during cancer treatment. Pembrolizumab helps the immune system attack cancer cells and may prevent them from growing and spreading. The study will see if propranolol can make the immune system more responsive to pembrolizumab in these patients.
Description
PRIMARY OBJECTIVE:
- To determine if propranolol can make tumors more responsive to pembrolizumab in patients with advanced triple negative breast cancer that has not responded to previous treatments.
SECONDARY OBJECTIVES:
- To evaluate how long patients live without the cancer getting worse and overall survival rates.
- To assess the safety and side effects of propranolol when used with pembrolizumab.
EXPLORATORY OBJECTIVES:
- To study changes in immune markers before and after treatment in blood and tumor samples.
- To explore the relationship between stress levels and immune markers in blood and tumor samples.
OUTLINE: Patients will take propranolol by mouth and receive pembrolizumab through an IV. They will have CT scans, blood tests, and may have a tumor biopsy before and during the study.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of advanced triple negative breast cancer that cannot be removed by surgery or has spread, with no other treatment options.
- Have not received chemotherapy, radiotherapy, or major surgery within 4 weeks before starting the study treatment.
- Have cancer that has stopped responding to previous chemotherapy and pembrolizumab, but can still continue with pembrolizumab according to the doctor.
- Agree to have a tumor biopsy before and 6 weeks after starting treatment.
- Use effective birth control if of childbearing potential, and inform the doctor immediately if pregnancy is suspected.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood counts and organ function as determined by specific tests.
- Be able to swallow and retain oral medication.
- Understand the study and agree to sign informed consent.
Exclusion Criteria
- Currently taking immunosuppressive medications, including steroids, until 3 weeks after stopping them.
- Have active autoimmune disease requiring ongoing treatment or a history of organ transplantation.
- Have rapidly progressing or symptomatic disease.
- Did not respond to initial treatment with chemotherapy and pembrolizumab.
- Are pregnant or breastfeeding.
- Have brain metastases that are symptomatic or treated less than 4 weeks ago.
- Have had another cancer within the past 5 years, except for certain low-risk cancers.
- Have uncontrolled illnesses, such as infections, heart failure, or psychiatric conditions that would interfere with the study.
- Have conditions that prevent the use of beta-blockers, such as severe asthma or uncontrolled diabetes.
- Have any other condition that makes participation in the study unsuitable according to the investigator.
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