Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Radiosurgery + Immunotherapy for Breast Cancer Brain Metastases
Phase 1
Waitlist Available
Led By Kamran Ahmed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
10 or less brain metastases eligible for SRS to brain metastases or to the post-operative bed
Breast cancer with brain metastases, as documented by extracranial tumor biopsy with MRI brain imaging or intracranial surgical pathology revealing brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6 and 12 months post treatment
Awards & highlights
Study Summary
This trial is testing whether adding radiosurgery to immunotherapy treatment will improve response rates in patients with metastatic breast cancer that has spread to the brain.
Who is the study for?
This trial is for adults with breast cancer that has spread to the brain. They must have had prior chemotherapy, no more than 10 brain metastases suitable for stereotactic radiosurgery (SRS), and a good performance status. Pregnant or breastfeeding women, those with leptomeningeal disease, previous whole-brain radiation therapy, certain viral infections, or inadequate organ function are excluded.Check my eligibility
What is being tested?
The study tests if giving SRS after Nivolumab improves tumor response in patients with metastatic breast cancer in the brain. It aims to see whether this combination can better manage brain tumors compared to current treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy like fatigue, skin issues, inflammation of organs (like lungs or intestines), and possible complications from radiation such as headaches or temporary hair loss at treatment sites.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 10 or fewer brain tumors eligible for targeted radiation.
Select...
My breast cancer has spread to my brain, confirmed by a biopsy and MRI.
Select...
My largest brain tumor is 4 cm or smaller.
Select...
I am 18 years old or older.
Select...
I have been treated with taxane and possibly anthracyclines.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3, 6 and 12 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6 and 12 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who experience Dose Limiting Toxicities
Secondary outcome measures
Evaluation of intracranial distant brain tumor following treatment
Brain
Extracranial Progression Free Survival (PFS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab followed by stereotactic radiosurgery (SRS)Experimental Treatment2 Interventions
480 mg Nivolumab will be given intravenously every 4 weeks, followed by SRS the week after the initial dose of Nivolumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,478 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,500 Total Patients Enrolled
51 Trials studying Breast Cancer
8,265 Patients Enrolled for Breast Cancer
Kamran Ahmed, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
156 Total Patients Enrolled
1 Trials studying Breast Cancer
31 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of testing positive for HIV or AIDS.I can provide a sample of my tumor for testing, or have tried to.I am not allergic to any of the drugs or their components used in this study.I have had whole brain radiation therapy before.I have not had cancer before, except for certain skin cancers, chronic leukemia, or other slow-growing cancers that didn't need treatment.I have 10 or fewer brain tumors eligible for targeted radiation.You are required to stay in a hospital or treatment center for a mental or physical illness.My breast cancer has spread to my brain, confirmed by a biopsy and MRI.My blood counts are low.My largest brain tumor is 4 cm or smaller.I am not pregnant or breastfeeding.Any side effects from my previous cancer treatments have mostly gone away.I have recovered from any major surgery or significant injury at least 14 days before starting the study drug.I am 18 years old or older.I have been treated with taxane and possibly anthracyclines.My cancer has spread to the lining of my brain and spinal cord.I have had SRS/FSRT but my current cancer has not been treated with radiation.You have a positive test for hepatitis B or C virus, except if you have a positive test for HCV antibody but no sign of current infection.I need extra oxygen to help me breathe.I can take care of myself and am up and about more than half of my waking hours.I do not have an active autoimmune disease requiring immunosuppressants.I have previously received immunotherapy targeting specific immune checkpoints.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.My liver isn't working well.My pancreas is not working properly.I am on hormonal or HER2 therapy and my brain cancer has worsened.Women who could become pregnant need to have a negative pregnancy test within 24 hours before each dose of the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab followed by stereotactic radiosurgery (SRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the eligibility criteria for participants of this scientific experiment?
"Going off the information provided on clinicaltrials.gov, this trial is not accepting new candidates at present. The study first appeared online in January of 2019 and was last updated November 17th 2022; however, there are 3850 other trials that are currently recruiting participants."
Answered by AI
What diseases does Nivolumab typically address?
"Generally, malignant neoplasms are treated with nivolumab. However, this therapy can also be effective at addressing unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma cases."
Answered by AI
Has a similar research effort been undertaken previously?
"Nivolumab research has been ongoing since 2012, when Ono Pharmaceutical Co. Ltd completed their initial study involving 659 subjects. This clinical trial was successful in gaining Phase 1 & 2 drug approval and now there are 717 active studies taking place across 49 countries and 2356 cities."
Answered by AI
To what extent does Nivolumab present a risk to patients?
"Data on Nivolumab's safety and effectiveness is limited, resulting in a score of 1."
Answered by AI
Have any other investigations explored the potential of Nivolumab?
"Currently, there are 717 active clinical trials involving nivolumab with 82 of them in their third stage. While many studies related to Nivolumab are held in Basel BE, 40281 other sites around the world also conduct research on this drug."
Answered by AI
What is the aggregate number of individuals who are participating in this experiment?
"This clinical trial has already concluded recruitment, with an initial posting date of January 30th 2019 and the last update being November 17th 2022. Fortunately, if you are searching for active trials, there are currently 3133 studies recruiting patients suffering from malignant neoplasms and 717 studies seeking participants to receive Nivolumab."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger