Pembrolizumab and Stereotactic Radiosurgery for Breast Cancer Brain Metastases
This study is looking at how well a combination of treatments works for women with metastatic breast cancer that has spread to the brain (brain metastases). You would receive pembrolizumab, a type of immunotherapy, along with stereotactic radiosurgery (SRS) to one of your brain tumors. Pembrolizumab is given as an infusion every three weeks. The study aims to see how well non-treated brain tumors respond to this combination and how long people live. To join, you must be a woman aged 19 to 90 with metastatic breast cancer and at least two measurable brain metastases. The study is currently unclear on its recruitment status and plans to enroll 41 participants.
- Study design
- This is an interventional study planning to enroll 41 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive pembrolizumab infusions every three weeks and undergo stereotactic radiosurgery (SRS) to one brain lesion. Treatment continues until your disease worsens or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed until death, with overall survival assessed for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03449238
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
Recruiting
PHASE1Ages 19–90InterventionalTreatmentWeill Medical College of Cornell UniversityInvestigator-initiated
~41 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Pembrolizumab
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.1
Measured over 8 weeks
+2 more outcomes measured
Conditions
Where it's being run
3 sites across 1 statesNew York3
Study leadership
- Silvia Formenti, M.D. · PRINCIPAL_INVESTIGATOR · Weill Cornell Medicine - New York Presbyterian Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 contrast enhanced MRI demonstrating at least 2 lesions in the brain, (≥3mm 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 standard of care.
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
Exclusion
Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
Patients who have undergone complete resection of all known brain metastases
Inability to obtain histologic proof of breast cancer
Target lesion metastasis within 5mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the SRS field
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy..Has a known history of Human Immunodeficiency Virus (HIV).
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Has a known history of active TB (Bacillus Tuberculosis).
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
What this trial measures
- Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.18 weeks
detect abscopal responses in non-irradiated brain metastases, followed at routine post SRS brain MRI (evaluated at 8 weeks post-treatment, +/- one week) according to Response Evaluation criteria in Solid Tumors (RECIST1.1)
- Correlation of abscopal responses with the radiation dose received1 year
Correlate potential abscopal responses with their radiation dose exposure
- Overall survival - assessed from the start of study drug until death in non-irradiation metastases in the rest of the body by routine imaging.3 years
detect systemic objective responses in non-irradiated metastases in the rest of the body, by routine imaging