Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
Summary
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.
Detailed description
Patients with metastatic breast cancer with at least 2 brain metastases, eligible to receive SRS. Patients will complete radiation therapy within 1 week and Pembrolizumab may be continued every 3 weeks until evidence of brain progression or serious adverse toxicity. Patients will be followed until death. 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.
Arms & interventions
- DrugPembrolizumab
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.
Outcome measures
Primary
Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.1
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)
Time frame: 8 weeks
Correlation of abscopal responses with the radiation dose received
Correlate potential abscopal responses with their radiation dose exposure
Time frame: 1 year
Overall survival - assessed from the start of study drug until death in non-irradiation metastases in the rest of the body by routine imaging.
detect systemic objective responses in non-irradiated metastases in the rest of the body, by routine imaging
Time frame: 3 years
Secondary
Number of participants with abscopal response will be assessed.
Time frame: up to 12 weeks
Eligibility criteria
Study locations (3)
Weill Cornell Medicine
New York, New York, 10065
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, 11215
New York Presbyterian Hospital - Queens
New York, New York, 11355