RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 90 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pembrolizumab with stereotactic radiosurgery (SRS), focused radiation given to one brain tumor. It is for adults with breast cancer that has spread to at least two places in the brain. Pembrolizumab is given through a vein every 3 weeks, starting about 4 days after SRS.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and able to do most daily activities.
  • Have breast cancer that has spread, with at least two untreated brain tumors measuring 3 mm or more.
  • Have a brain MRI with contrast dye within 2 weeks before treatment. Tumors treated in this study must be smaller than 4 cm.
  • Have cancer that can be measured under study rules. Previously radiated areas must show cancer growth to count.
  • Prior SRS is allowed, but not for tumors targeted in this study. Prior surgery that removed only part of a tumor is allowed if the remaining tumor is smaller than 4 cm.
  • Have a 2-week break after the last whole-body cancer treatment. Hormone or anti-HER2 treatment may continue if brain tumors grew during that treatment.
  • Have enough blood-forming cells in the bone marrow and good enough liver function.
  • Understand and give written consent, with a legal representative if needed, and follow the 120-day birth control requirement.

Who can't join

  • All known brain tumors were fully removed, breast cancer cannot be confirmed with a tissue sample, or a target tumor is too close to nerves used for sight.
  • Radiation within 2 weeks before study treatment, ongoing radiation side effects, steroid needs, or lung inflammation from radiation. Some short courses of symptom-relief radiation outside the brain allow a 1-week break.
  • A live vaccine within 30 days, or an experimental drug or device within 4 weeks before study treatment.
  • A weak immune system, recent medicines that weaken it, or long-term steroids above the allowed dose; active immune disease needing whole-body treatment in the past 2 years; or lupus or similar disease needing flare treatment.
  • Another cancer that is growing or needed treatment in the past 3 years, except certain treated skin or very early cancers; or a severe allergy to pembrolizumab or its ingredients.
  • Current lung inflammation, past lung inflammation needing steroids, an infection needing whole-body treatment, known HIV or hepatitis B, active hepatitis C, or a known history of active tuberculosis.
  • A mental health or substance use disorder that would prevent following study requirements.
  • Pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within 120 days after the last dose.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 Criteria: * 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.

Study sites (3)

NY