drugset / Trial / NCT03112590
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
Phase 1/2
Completed
51 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Horizon Pharma Ireland, Ltd., Dublin Ireland · collab
NaSequentialOpen-labelTreatment
Summary
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer. Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.
Timeline
- Start
- 2017-06-23
- Primary completion
- 2021-03-31
- Completion
- 2023-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 50 ug/m2 | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 75 ug/m2 | Subcutaneous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |