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New treatment option for Anatomic Stage III Breast Cancer AJCC v8
Official title Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT05741164
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage iii breast cancer ajcc v8.
Also referred to as Keytruda, Lambrolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Patients must be agreeable to pre- and 6-week post treatment biopsy in part 1 of the study
You likely can't join if
- Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 \ 8.5 or fasting plasma glucose...
- Any additional condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.