The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer (NCT03414658)
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
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- University of California San Francisco — San Francisco, California
- Georgetown University Medical Center — Washington D.C., District of Columbia
- University of Chicago Medical Center — Chicago, Illinois
- Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana
- Johns Hopkins University — Baltimore, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Memorial Sloan-Kettering Cancer Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- University of Carolina at Chapel Hill — Chapel Hill, North Carolina
- Duke University Medical Center — Durham, North Carolina
- University of Pennsylvania — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- Baylor College of Medicine — Houston, Texas
- MD Anderson Cancer Center — Houston, Texas
- University of Washington Fred Hutchinson Cancer Care — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.