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Monoclonal Antibodies
Atezolizumab + Pertuzumab + Trastuzumab for Breast Cancer with Brain Metastases
Phase 2
Waitlist Available
Research Sponsored by Nancy Lin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unequivocal evidence of new and/or progressive brain metastases with specific treatment scenarios
Presence of at least one measurable CNS metastasis of a certain size
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well atezolizumab works compared to standard of care in treating patients with HER2-positive metastatic breast cancer that has spread to the brain.
Who is the study for?
This trial is for adults with HER2-positive metastatic breast cancer that has spread to the brain. Participants must be in good physical condition (ECOG 0 or 1), not pregnant, and agree to use contraception. They can't have had major surgery recently, be on high-dose steroids or immunosuppressants, have certain other cancers or infections, or have received some treatments within specific time frames.Check my eligibility
What is being tested?
The study tests atezolizumab combined with pertuzumab and trastuzumab as a treatment for breast cancer that has metastasized to the brain. It's assessing how well these drugs work together and their safety in patients who meet strict eligibility criteria regarding health status and previous treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation of organs, infusion-related reactions like fever or chills, fatigue, possible heart issues due to trastuzumab's known effects on heart function, allergic responses similar to past allergies participants may have had towards compounds in these drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to my brain and is getting worse.
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I have a brain tumor of a specific size that can be measured.
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I am not receiving any other cancer treatments during this study.
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My breast cancer is confirmed to be HER2-positive by tests.
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I am 18 years old or older.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate in CNS
Secondary outcome measures
Clinical Benefit Rate
Dose Limiting Toxicity
Duration Response Rate
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMABExperimental Treatment3 Interventions
Patients will receive the following treatment:
Atezolizumab (IV) every 3 weeks (q3w)]
Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV)
High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRASTUZUMAB
2014
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,656 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Nancy Lin, MDLead Sponsor
3 Previous Clinical Trials
137 Total Patients Enrolled
3 Trials studying Breast Cancer
137 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or have had a bad reaction to trastuzumab, pertuzumab, or atezolizumab.My cancer has spread to the brain or its coverings.I've been on a stable dose of dexamethasone (2mg or less) for at least a week.My cancer has spread to my brain and is getting worse.I have previously received treatments targeting the immune system.I have lung problems or my cancer has spread widely in my lungs.I have a brain tumor of a specific size that can be measured.I am not receiving any other cancer treatments during this study.I am not pregnant and agree to use birth control.I have not received a live vaccine in the last 28 days.I have not had major surgery in the last 3 weeks.I am not on IV antibiotics for an infection as I start this treatment.I haven't had chemotherapy or targeted therapy in the last 14 days.I have another cancer that is serious and could threaten my life.My heart's pumping ability is normal, confirmed by a recent heart scan.My blood tests for organ and bone marrow function are normal.I need urgent brain surgery due to complications.You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.My breast cancer is confirmed to be HER2-positive by tests.My condition is not in a critical state affecting my internal organs.I am 18 years old or older.I haven't used any experimental treatments in the last 14 days.I cannot have MRI scans with gadolinium contrast.I am fully active or can carry out light work.You have had a bad reaction to drugs similar to atezolizumab.I understand the study requirements and have signed the consent form.I am on long-term steroids or other drugs that weaken my immune system.I haven't taken high dose steroids in the last 7 days.I do not have any uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB
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.
Is there scope to enroll additional participants in this trial?
"This medical trial is presently not open for recruitment. The study was initially available on May 21st, 2018 and has since been updated as of March 14th 2022. Other studies related to neoplasm metastasis have 2871 enrolling participants while 528 trials are looking for those interested in ATEZOLIZUMAB."
Answered by AI
How many individuals have enrolled in this trial thus far?
"Unfortunately, no new participants are being recruited into this trial at the moment. Data on clinicaltrials.gov shows that it was first posted in May of 2018 and was last updated in March 2022. If you're interested in alternative medical studies, there are presently 2871 trials for neoplasm metastasis and 528 involving ATEZOLIZUMAB enrolling patients right now."
Answered by AI
Has ATEZOLIZUMAB been granted regulatory authorization by the FDA?
"Our team at Power has determined that ATEZOLIZUMAB is relatively safe, as indicated by a score of 2. This assessment was based on the fact that this trial is in its second phase, which provides some evidence for safety but no data supporting efficacy."
Answered by AI
Could you provide a summary of prior experiments conducted with ATEZOLIZUMAB?
"Initially studied in 1999, ATEZOLIZUMAB has since been subject to 451 completed clinical trials. Currently 528 more are active with a substantial portion being conducted out of Chicago."
Answered by AI
In what medical applications is ATEZOLIZUMAB most regularly employed?
"The brca1 gene is often treated via ATEZOLIZUMAB, which can also have efficacy for conditions like pharmacotherapy, IBC (Inflammatory Breast cancer), and SCLC (Small cell lung cancer)."
Answered by AI
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