RecruitingPhase 1Phase 2NCT03449238

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients


Sponsor

Weill Medical College of Cornell University

Enrollment

41 participants

Start Date

Nov 15, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether the immunotherapy drug pembrolizumab (Keytruda) combined with focused radiation to a few brain metastases (stereotactic radiosurgery) can improve outcomes for breast cancer patients whose cancer has spread to the brain. **You may be eligible if...** - You are 18 years or older - You are in generally good health (ECOG status 0–1) with adequate neurological function - You have metastatic breast cancer with at least 2 and no more than 10 brain tumors (each at least 5mm in size) that have not been previously treated - The brain tumors are visible on a contrast MRI scan done within 2 weeks before treatment - Each tumor to be treated is smaller than 4 cm **You may NOT be eligible if...** - You have more than 10 brain metastases - Your tumor is too large (4 cm or more) - You have previously received immune checkpoint therapy - You have active autoimmune disease or are on systemic steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

Weill Cornell Medicine

New York, New York, United States

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States

New York Presbyterian Hospital - Queens

New York, New York, United States

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NCT03449238


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