Title: 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: Adrienne Waks, MD, PhD, of Dana Farber Cancer Institute in Boston, Massachusetts

Description: Researchers are conducting a phase 2 study to compare trastuzumab-based combinations in patients with advanced HER2-positive breast cancer.

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The combinations are trastuzumab plus vinorelbine; trastuzumab plus vinorelbine and avelumab; and trastuzumab plus vinorelbine, avelumab, and utomilumab. The study also includes a crossover arm in which patients will receive trastuzumab plus avelumab and utomilumab.

In all arms, patients will receive trastuzumab twice per cycle. Among patients assigned to the additional drugs, vinorelbine will be given 3 times per cycle, avelumab twice per cycle, and utomilumab once per cycle. Patients will also receive an antihistamine and acetaminophen 30 to 60 minutes prior to each dose of avelumab.

The primary outcome is progression-free survival. Secondary outcome measures include objective response rate, duration of response, overall survival, and safety and tolerability.

To be eligible for this study, patients must be 18 years of age and older. They must have a histologically confirmed diagnosis of unresectable, locally advanced or metastatic HER2-positive breast cancer. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Adrienne Waks in collaboration with Pfizer, the Breast Cancer Research Foundation, and Johns Hopkins University.


ClinicalTrials.gov. The AVIATOR study: Trastuzumab and vinorelbine with avelumab or avelumab and utomilumab in advanced HER2+ breast cancer. NCT03414658. Accessed November 21, 2022.