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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

Must not have

Known intolerance to trastuzumab or pertuzumab or atezolizumab

Known leptomeningeal or brainstem metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or have had a bad reaction to trastuzumab, pertuzumab, or atezolizumab.

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My cancer has spread to the brain or its coverings.

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I have previously received treatments targeting the immune system.

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I have lung problems or my cancer has spread widely in my lungs.

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I have not had major surgery in the last 3 weeks.

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I am not on IV antibiotics for an infection as I start this treatment.

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I haven't had chemotherapy or targeted therapy in the last 14 days.

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I have another cancer that is serious and could threaten my life.

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I need urgent brain surgery due to complications.

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My condition is not in a critical state affecting my internal organs.

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I cannot have MRI scans with gadolinium contrast.

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I am on long-term steroids or other drugs that weaken my immune system.

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I haven't taken high dose steroids in the last 7 days.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed Overall Response Rate in CNS

Secondary study objectives

Clinical Benefit Rate in CNS at 18 Weeks

Clinical Benefit Rate in CNS at 24 Weeks

Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 20Eligibility criteria met