TBCRC045-AVIATOR for HER2+ Metastatic Breast Cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test if 3 different drug combinations will work in people with metastatic HER2 positive breast cancer.
Who Can Participate in the Study?
Women with HER2 positive metastatic breast cancer who:
- Previously had treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting
- Have previously gotten trastuzumab and pertuzumab in the metastatic setting
- Had their disease get worse during their most recent line of therapy
What is Involved?
If you choose to join the study, you will:
- Be randomized (as in pulling numbers from a hat) into one of three groups:
-- Group A: will get trastuzumab and vinorelbine combined
-- Group B: will get trastuzumab, vinorelbine, and avelumab combined
-- Group C: will get trastuzumab, vinorelbine, avelumab and utomilumab combined
- Have a biopsy before starting therapy, as well as Cycle 3 Day 1
- Have blood drawn at every other cycle to test for biomarkers