Is NCT05741164 recruiting in Atlanta, GA?

Yes, NCT05741164 is currently recruiting participants at its Atlanta, GA location. This anatomic stage iii breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial in Atlanta, GA

Q: How do I join the anatomic stage iii breast cancer ajcc v8 clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage III Breast Cancer AJCC v8 Study in Atlanta

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. Beta-blockers affect the heart and circulation. Beta-blockers, like propranolol, may help to counteract effects of certain stress hormones produced by the body during cancer treatment and may increase the effectiveness of the pembrolizumab. Pembrolizumab is a drug that is classified as an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Propranolol may be able to re-sensitize the cells of the immune system to respond to the checkpoint inhibitor pembrolizumab in patients with checkpoint inhibitor refractory metastatic or unresectable triple negative breast cancer.

Sponsor: Emory University

Who Can Participate

Inclusion 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 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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT05741164) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage III Breast Cancer AJCC v8 Treatment Options in Atlanta, GA

If you're searching for anatomic stage iii breast cancer ajcc v8 treatment options in Atlanta, GA, this clinical trial (NCT05741164) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage iii breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage iii breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial in Atlanta, GA

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