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The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

NCT03414658 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-02

Study results available
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Summary

This research study is studying a combination of drugs as a possible treatment for breast cancer.

The drugs involved in this study are:

* Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine)
* Group B: Trastuzumab + Vinorelbine + Avelumab
* Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

Conditions

Interventions

DRUG

Vinorelbine

work by interfering with cell division, which leaves the tumor unable to grow and spread

DRUG

Trastuzumab

trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.

DRUG

Avelumab

monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein

DRUG

Utomilumab

Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Adrienne G. Waks

    lead OTHER

Principal Investigators

  • Adrienne Waks, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2023-05-01
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03414658 on ClinicalTrials.gov