The AVIATOR Study: Testing Drug Combinations for Advanced HER2+ Breast Cancer
Sponsor: Adrienne G. Waks
ClinicalTrials ID:NCT03414658
This clinical trial is exploring different combinations of drugs to see if they can effectively treat advanced HER2-positive breast cancer. The study involves three groups, each receiving a different combination of medications, including Trastuzumab, Vinorelbine, Avelumab, and Utomilumab.
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Program Overview
This study is testing a combination of drugs to see if they can help treat advanced HER2-positive breast cancer. The drugs being tested are Trastuzumab, Vinorelbine, Avelumab, and Utomilumab. The study is divided into three groups: one group receives Trastuzumab and Vinorelbine, another group receives these two drugs plus Avelumab, and the third group receives all four drugs. The goal is to find out if these combinations are safe and effective in treating this type of breast cancer.
Description
This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new combination of drugs to see if they work for treating a specific disease. In this case, the disease is advanced HER2-positive breast cancer. The drugs being tested include Trastuzumab, which is already approved for this type of cancer, and Vinorelbine, which is approved for other diseases but commonly used for breast cancer. Avelumab is approved for other diseases, but Utomilumab is still being studied and not yet approved for any disease.
The immune system helps protect the body from diseases, including cancer. Some cancer cells can hide from the immune system by using a pathway called PD-1. Avelumab is a drug that blocks this pathway, helping the immune system detect and fight cancer cells. Utomilumab is another drug that may help the immune system fight cancer. In lab studies, adding Avelumab and Utomilumab to Trastuzumab seems to improve effectiveness, but it is not yet known if this is true in humans.
The study is looking at how well these drug combinations work in people with metastatic HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced or metastatic HER2-positive breast cancer that cannot be surgically removed.
- Have measurable disease based on specific medical criteria.
- Must have previously been treated with certain cancer drugs, including ado-trastuzumab emtansine (Kadcyla, T-DM1), trastuzumab, and pertuzumab.
- Cancer must have progressed on the most recent treatment.
- Heart function must be at a certain level (LVEF ≥ 50%).
- Must be willing to provide a tissue sample for testing.
- Must be in good overall health with a performance status of 0-1.
- Must have adequate blood cell counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Must not be breastfeeding.
Exclusion Criteria
- Have had previous treatments with certain immune therapies.
- Have HIV, Hepatitis B, or Hepatitis C.
- Have a history of lung disease or active brain metastases.
- Have significant heart disease or uncontrolled medical conditions.
- Have had severe allergic reactions to similar treatments.
- Have active infections or require systemic therapy with immunosuppressive agents.
- Have autoimmune diseases requiring treatment.
- Have uncontrolled high blood pressure, unstable diabetes, or need oxygen therapy.
- Have received cancer treatment within 3 weeks before the study or have unresolved side effects from previous treatments.
- Have received live vaccines within 30 days before the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35249 | Birmingham | Alabama |
| University of California San Francisco | 94158 | San Francisco | California |
| Georgetown University Medical Center | 20007 | Washington D.C. | District of Columbia |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| Indiana University Health Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Johns Hopkins University | 21287 | Baltimore | Maryland |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| Montefiore Medical Center | 10467 | The Bronx | New York |
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