Pembrolizumab + SRS for Brain Metastases from Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires a two-week washout period (time without taking certain medications) from your last systemic treatment before starting the study. However, you can continue using hormonal therapy or anti-Her2 neu therapy if your brain metastases are progressing during these treatments.
Is the combination of Pembrolizumab and SRS safe for treating brain metastases?
What makes the drug pembrolizumab unique for treating brain metastases from breast cancer?
Pembrolizumab is unique because it is an immunotherapy drug that works by blocking a protein called PD-1, which helps the immune system attack cancer cells, including those in the brain. This approach is novel for brain metastases, as traditional treatments often do not focus on enhancing the immune response.46789
What data supports the effectiveness of the drug pembrolizumab for treating brain metastases from breast cancer?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has been effective in treating brain metastases from various cancers, with 42.1% of patients experiencing benefits like tumor shrinkage or stabilization. This suggests it might also help some patients with brain metastases from breast cancer.1471011
Who Is on the Research Team?
Silvia Formenti
Principal Investigator
Weill Cornell Medicine - New York Presbyterian Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with metastatic breast cancer and at least two untreated brain metastases visible on MRI. Participants must have good performance status, adequate organ function, and agree to use contraception. Exclusions include recent radiation therapy or immunosuppressive treatment, active infections, other cancers within the past 3 years, severe allergies to pembrolizumab components, certain viral infections like Hepatitis B/C or HIV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo stereotactic radiosurgery (SRS) to one of the brain lesions
Treatment
Pembrolizumab infusion given every 3 weeks until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Stereotactic Radiosurgery (SRS)
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University