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Pembrolizumab + SRS for Brain Metastases from Breast Cancer
Study Summary
This trial is testing a new way to treat breast cancer that has spread to the brain. Patients will receive a drug called pembrolizumab, which will be given before they undergo a type of radiation treatment called stereotactic radiosurgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have an active connective tissue disorder like lupus or scleroderma needing treatment for flares.I have not received a live vaccine within the last 30 days.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have another cancer besides skin or early cervical cancer that needed treatment in the last 3 years.I have had lung inflammation that needed steroids or have it now.You have been diagnosed with HIV.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am currently being treated for an infection.My MRI shows 2-10 brain lesions, each at least 5mm, identified within the last two weeks.I have had SRS before, but the areas we're looking to treat now haven't been treated with SRS.I had a partial tumor removal, and any remaining tumor is smaller than 4cm. I can continue hormone or anti-HER2 therapy if my brain cancer worsens.I had radiotherapy over 2 weeks ago, recovered from side effects, and don't need steroids.I am fully active or can carry out light work.My neurological function is normal or slightly impaired.I have breast cancer that has spread to my brain with at least 2 tumors larger than 5mm.My bone marrow and liver are functioning well.You have a very severe allergic reaction to pembrolizumab or any of its ingredients.You have been using contraception for at least 120 days.I have had surgery to remove all detected brain tumors.I have a history of Hepatitis B or active Hepatitis C.I have an active tuberculosis infection.I have not had any cancer treatments in the last two weeks.My cancer can be measured and has grown in previously treated areas.I am older than 18 years.My cancer has spread near my optic nerve.The largest area affected by my cancer is smaller than 4cm.You cannot provide a tissue sample to confirm that you have breast cancer.
- Group 1: Pembrolizumab and SRS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies left in this experiment for willing participants?
"Data sourced from clinicaltrials.gov reveals that this medical trial is actively recruiting participants as of June 29th 2022, with the initial post being on November 15th 2018."
In what instances is this procedure routinely prescribed?
"This treatment is primarily used to quell malignant neoplasms, but can also be beneficial for patients suffering from unresectable melanoma and microsatellite instability high. Additionally, it has been known to provide relief after chemotherapy treatments have ceased working."
Who can partake in the clinical experiment?
"This medical trial seeks 41 individuals aged 19 to 90 with brain cancer who meet the following requirements: an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a Neurological function status between 0 and 2, pre or post menopausal women exhibiting metastatic breast cancer with at least two intracranial untreated lesions visible on MRI scans measuring 5mm in size. The maximum diameter of these lesions should be 4cm or less while they cannot have been previously treated by Stereotactic Radiosurgery (SRS). Trial participants must demonstrate their willingness to sign a written informed consent document as well as agree to"
What prior experiments have explored the efficacy of this therapy?
"Currently, 961 trials are actively researching this treatment. Of those studies, 122 have entered Phase 3 clinical trial stages. These live research efforts mainly originate from Houston, TX; however they extend to 35,727 other sites globally."
What is the aggregate number of participants in this clinical investigation?
"Affirmative. The clinical trial is presently seeking out volunteers and the post on clinicaltrials.gov was initially created in November 2018, with its most recent revision taking place in June 2022. A total of 41 individuals will be recruited from 3 distinct medical centres for this research project."
Does this experimental trial accept participants over the age of fifty-five?
"As stipulated by the trial's requirements, individuals aged 19-90 are qualified to participate."
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