NCT03449238 · Weill Medical College of Cornell University
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
What this study is about
Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.
View original scientific description
Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.
Interventions
DRUG
Pembrolizumab
Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.
Primary outcome measures
Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.1
Time frame: 8 weeks
detect abscopal responses in non-irradiated brain metastases, followed at routine post SRS brain MRI (evaluated at 8 weeks post-treatment, +/- one week) according to Response Evaluation criteria in Solid Tumors (RECIST1.1)
Correlation of abscopal responses with the radiation dose received
Time frame: 1 year
Correlate potential abscopal responses with their radiation dose exposure
Overall survival - assessed from the start of study drug until death in non-irradiation metastases in the rest of the body by routine imaging.
Time frame: 3 years
detect systemic objective responses in non-irradiated metastases in the rest of the body, by routine imaging
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age older than 18
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Neurological function status 0, 1, 2
- Men and/or pre- or post-menopausal women with metastatic breast cancer with at least 2 intracranial untreated and measurable (≥ 5mm) metastases as visualized on brain MRI
- A diagnostic contrast enhanced MRI demonstrating at least 2 and no more than 10 measurable lesions in the brain, (≥5mm in size), performed within two weeks prior to treatment
- Maximum diameter of treated lesions should be \<4cm in size
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
- Prior SRS is permitted, however the lesions targeted for treatment on trial need to be previously untreated by SRS
- Patients who have undergone prior
Where
- New York, New York
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations