The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
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)
Timeline
- Start
- 2018-06-21
- Primary completion
- 2023-05-01
- Completion
- 2027-05-31
Outcome
Mixed primary results
registry analysis (superiority test); NH: Trastuzumab + Vinorelbine vs NHA: Trastuzumab + Vinorelbine + Avelumab; p = 0.025; Hazard Ratio (HR) 0.53 (80% CI 0.35 to 0.81); Log Rank NCT03414658 ↗
registry analysis (superiority test); NHA: Trastuzumab + Vinorelbine + Avelumab vs NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab; p = 0.32; Hazard Ratio (HR) 1.14 (80% CI 0.8 to 1.64); Log Rank NCT03414658 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | — | Intravenous |
| Subject | Vinorelbine | Small molecule | — | Intravenous |