Study Summary
This trial is testing a new way to treat breast cancer that has spread to the brain. Patients will receive a drug called pembrolizumab, which will be given before they undergo a type of radiation treatment called stereotactic radiosurgery.
Eligible Conditions
- Metastatic Breast Cancer
- Metastatic Brain Tumors
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: 3 years
1 year
Correlation of abscopal responses with the radiation dose received
3 years
Overall survival - assessed from the start of study drug until death in non-irradiation metastases in the rest of the body by routine imaging.
8 weeks
Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.1
up to 12 weeks
Number of participants with abscopal response will be assessed.
Trial Safety
Safety Progress
Trial Design
0 Treatment Group
41 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,674 Previous Clinical Trials
4,959,359 Total Patients Enrolled
12 Trials studying Metastatic Breast Cancer
30,462 Patients Enrolled for Metastatic Breast Cancer
Weill Medical College of Cornell UniversityLead Sponsor
986 Previous Clinical Trials
1,338,464 Total Patients Enrolled
4 Trials studying Metastatic Breast Cancer
71 Patients Enrolled for Metastatic Breast Cancer
Silvia Formenti, M.D.Principal InvestigatorWeill Cornell Medicine - New York Presbyterian Hospital
10 Previous Clinical Trials
1,181 Total Patients Enrolled
1 Trials studying Metastatic Breast Cancer
23 Patients Enrolled for Metastatic Breast Cancer
Eligibility Criteria
Age 19 - 90 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a performance status of 0 or 1.
You have 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.
You have a maximum lesion diameter of <4cm.
You have measurable disease based on RECIST 1.1
Patient must be able to understand and demonstrate willingness to sign a written informed consent document.
Patients must be younger than 18 years old.\n
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Conditions
Cancer Related
Treatments