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Propranolol and Pembrolizumab for Triple-Negative Breast Cancer

This study is testing if combining two drugs, propranolol and pembrolizumab, can help treat metastatic or unresectable triple-negative breast cancer that has not responded to previous immunotherapy (checkpoint inhibitor refractory). Propranolol is a beta-blocker that may help pembrolizumab, an immunotherapy drug, work better by counteracting stress hormones. The goal is to see if this combination can make tumors more responsive to treatment. You may be eligible if you are an adult woman with this type of breast cancer that has spread or cannot be removed by surgery, and you haven't had recent chemotherapy, radiation, or major surgery. The main way success will be measured is by looking at how many tumors shrink or disappear within 6 months. The current status of this study is unclear, and it plans to enroll 37 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 37 adult women.
What's involved
Participants will receive propranolol by mouth and pembrolizumab through an IV. You will undergo CT scans, blood draws, and may have a tumor biopsy during screening and throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for treatment response is measured up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05741164

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~37 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyPembrolizumabPropranololQuestionnaire Administration

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response
Measured over Up to 6 months

Conditions

Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma
Refractory Triple-Negative Breast Carcinoma
Unresectable Triple-Negative Breast Carcinoma

Explore related trials

Triple-Negative Breast Carcinoma

Where it's being run

2 sites across 2 states
Georgia1
New York1

Study leadership

  • Shipra Gandhi, MD, MS · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Shipra Gandhi, MD, MS
[email protected]
404-778-1900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Patients must be agreeable to pre- and 6-week post treatment biopsy in part 1 of the study
The pre-treatment biopsy for this study must be taken at least 4 weeks after all previous chemotherapy (pembrolizumab is allowed during this period)
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g. hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of =\< 1
Platelets \>= 100,000/uL
Hemoglobin \>= 9.0 g/dL
Absolute neutrophil count (ANC) \>= 1500/uL
Total bilirubin =\< institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN
Creatinine clearance \>= 50 mL/min per Cockcroft-Gault equation
HbA1C \<=8.5
Have measurable disease per RECIST 1.1 criteria present
Ability to swallow and retain oral medication
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion

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
Patients who are pregnant or nursing. Women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening
Participants with symptomatic known brain metastases \< 4 weeks from radiation treatment should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastases or death
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Unwilling or unable to follow protocol requirements
Contraindications to the use of beta-blockers, like: uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (grade III or IV), hypotension (systolic blood pressure \< 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (hemoglobin A1C \[HbA1C\] \> 8.5 or fasting plasma glucose \> 160 mg/dl at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current use of beta-blockers or non-dihydropyridine calcium channel blockers
Any additional condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs

What this trial measures

  • Objective responseUp to 6 months

    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.