BridgeMD
New treatment option for Metastatic Breast Cancer
Official title Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
ClinicalTrials.gov ID: NCT03449238
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 90, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.