Study on Atezolizumab, Pertuzumab, and Trastuzumab for Treating Brain Metastases in HER2-Positive Breast Cancer
Sponsor: Nancy Lin, MD
ClinicalTrials ID:NCT03417544
This clinical trial is exploring the use of atezolizumab, along with pertuzumab and trastuzumab, to treat HER2-positive breast cancer that has spread to the brain. The study aims to determine if this combination can effectively manage the disease.
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Program Overview
This research is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment combination for HER2-positive breast cancer that has spread to the brain. The treatment involves three drugs: atezolizumab, pertuzumab, and trastuzumab. Atezolizumab helps the immune system recognize and attack cancer cells by blocking a pathway that usually prevents the immune system from working properly. Pertuzumab and trastuzumab are targeted therapies that attach to specific receptors on cancer cells, blocking signals that tell the cells to grow and marking them for destruction by the immune system. This study is investigating how well this combination works in controlling the cancer.
Description
This study is testing a new combination of drugs for treating HER2-positive breast cancer that has spread to the brain. The drugs involved are atezolizumab, pertuzumab, and trastuzumab. Atezolizumab is an investigational drug that helps the immune system attack cancer cells by blocking a pathway that usually prevents the immune system from working properly. Pertuzumab and trastuzumab are already approved for treating HER2-positive breast cancer and work by attaching to specific receptors on cancer cells, blocking growth signals, and marking the cells for destruction by the immune system. The study aims to see if adding atezolizumab to pertuzumab and trastuzumab can improve treatment outcomes for patients with brain metastases from HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of HER2-positive metastatic breast cancer with specific lab requirements.
- At least one measurable brain metastasis that is 10 mm or larger.
- Evidence of new or growing brain metastases, with specific conditions for previous treatments.
- ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Heart function with an ejection fraction of 50% or higher.
- Stable dose of dexamethasone 2mg or less for at least 7 days before starting treatment.
- No other anti-cancer therapy during the study, but supportive care medications are allowed.
- Age 18 or older.
- Normal organ and marrow function based on specific blood test results.
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and after the study.
- Ability to understand and sign the informed consent document.
Exclusion Criteria
- Urgent need for neurosurgical intervention for brain complications.
- Known leptomeningeal or brainstem metastases.
- High dose systemic corticosteroids within 7 days of starting therapy.
- Inability to undergo MRI with contrast.
- Recent chemotherapy or targeted therapy within 14 days before starting the study.
- Previous treatment with certain immune therapies.
- Use of investigational treatments within 14 days before starting the study.
- Allergies to similar drugs as those in the study.
- Uncontrolled illnesses, including infections, heart conditions, or diabetes.
- Pregnancy or breastfeeding.
- Recent major surgery or active infection requiring IV antibiotics.
- Need for chronic systemic steroid therapy or immunosuppressive medication.
- Lung disease causing shortness of breath at rest.
- Positive for HIV, Hepatitis B, or Hepatitis C.
- Recent live vaccine within 28 days of starting the study.
- Known intolerance to any of the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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