NCT03449238

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Brain Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-15
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2018-02-28
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study