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.

What is the Condition Being Studied?

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

Age Group

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

Study Details

Full Title
AVIATOR: TBCRC045 (DF/HCC 17-455): A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination with Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients with HER2-Positive Metastatic Breast Cancer who have Progressed on Prior Trastuzumab and Pertuzumab.
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00100629
NCT: NCT03414658
Phase II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center