Actively Recruiting
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
Led by Weill Medical College of Cornell University · Updated on 2026-03-30
41
Participants Needed
3
Research Sites
632 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Female patients with metastatic breast cancer with at least 2 untreated and measurable brain metastases (≥3mm)
- Diagnostic contrast-enhanced MRI within two weeks showing at least 2 brain lesions (≥3mm)
- Maximum diameter of treated lesions less than 4cm
- Measurable disease based on RECIST 1.1 criteria
- Ability to understand and sign informed consent
- Prior SRS allowed if targeted lesions are untreated
- Prior subtotal resection allowed with residual disease less than 4cm
- Concurrent hormonal or anti-Her2 neu therapy allowed if brain metastases are progressing
- Two-week washout from last systemic treatment before enrollment
- Written informed consent provided by participant or legal representative
- Use of contraception for 120 days
- Adequate bone marrow and liver function
You will not qualify if you...
- Active connective tissue disorders requiring flare therapy
- Complete resection of all known brain metastases
- Inability to obtain breast cancer histologic proof
- Brain metastasis within 5mm of optic apparatus preventing safe SRS
- Radiotherapy within 2 weeks before study treatment start
- Live vaccine within 30 days before first study drug dose
- Participation in investigational study or device use within 4 weeks before first dose
- Immunodeficiency or chronic systemic steroid use exceeding 10 mg prednisone daily within 7 days before first dose
- Known progressing second malignancy requiring treatment within 3 years
- Severe hypersensitivity to pembrolizumab or excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV, active Hepatitis B or C infection
- Known active tuberculosis
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy, breastfeeding, or planning pregnancy during study and 120 days after last dose
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
2
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States, 11215
Actively Recruiting
3
New York Presbyterian Hospital - Queens
New York, New York, United States, 11355
Actively Recruiting
Research Team
F
Fabiana Gregucci, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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