Pembrolizumab and Stereotactic Radiosurgery for Brain Metastases

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

Recruiting Phase 1 Phase 2 Interventional Study
Metastatic Breast Cancer Brain Metastases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
19 – 90
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
41 (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Who this trial is looking for

This trial is looking for adults with metastatic breast cancer who have at least 2 brain tumors. Participants will receive pembrolizumab every 3 weeks and undergo a specific type of radiation therapy for one of their brain tumors.

Are You a Good Fit for This Trial?
Rules you out ImmunodeficiencyActive TBHIVHepatitis BHepatitis C

You may be able to join if

  • I am older than 18 years old.
  • I have been diagnosed with metastatic breast cancer.
  • I have at least 2 untreated brain tumors that are 3mm or larger.
  • I can understand and sign a consent form for the trial.
  • I had an MRI showing my brain tumors done within the last two weeks.
  • I have a maximum tumor size of less than 4cm.
  • I have enough bone marrow and liver function.
  • I have taken a break of at least two weeks from my last treatment.

You may not be able to join if

  • I have active autoimmune disease that has needed treatment in the past 2 years.
  • I cannot provide proof of breast cancer diagnosis.
  • I have had complete removal of all brain tumors.
  • I have received radiation therapy within 2 weeks of starting this trial.
  • I have active infections that require systemic therapy.
  • I am pregnant or breastfeeding.
  • I have severe allergies to pembrolizumab.
  • I have a history of certain serious lung problems.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age older than 18 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Men and/or pre- or post-menopausal women with metastatic breast cancer with at least 2 intracranial untreated and measurable (≥ 3mm) metastases as visualized on brain MRI * A diagnostic cont…
Contacts

Fabiana Gregucci, M.D.

646-962-3110

fgr4002@med.cornell.edu

CONTACT