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

Who is this study for? Adult female patients with Brain Tumors
What treatments are being studied? Pembrolizumab
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 90
Healthy Volunteers: f
View:

• Age older than 18

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Neurological function status 0, 1, 2

• Men and/or pre- or post-menopausal women with metastatic breast cancer with at least 2 intracranial untreated and measurable (≥ 5mm) metastases as visualized on brain MRI

• A diagnostic contrast enhanced MRI demonstrating at least 2 and no more than 10 measurable lesions in the brain, (≥5mm in size), performed within two weeks prior to treatment

• Maximum diameter of treated lesions should be \<4cm in size

• Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

• Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

• Prior SRS is permitted, however the lesions targeted for treatment on trial need to be previously untreated by SRS

• Patients who have undergone prior subtotal resection are eligible providing that residual disease is \<4cm in maximum diameter: the cavity will be treated as - - - Continuing a concurrent use of hormonal therapy or anti-Her2 neu therapy is allowed, if the patient exhibits brain metastases progression during these treatments

• Enrolled patients should have a two-week washout period from last systemic treatment

• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

• Contraception duration of 120 days

• Adequate bone marrow reserve and liver function

Locations
United States
New York
Brooklyn Methodist Hospital - NewYork Presbyterian
RECRUITING
New York
New York Presbyterian Hospital - Queens
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Fabiana Gregucci, M.D.
fgr4002@med.cornell.edu
646-962-3110
Time Frame
Start Date: 2018-11-15
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 41
Treatments
Other: Pembrolizumab and SRS
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.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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