Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer
Summary
The purpose of this study is to examine the safety and efficacy of Ruxolitinib in combination with Trastuzumab in treatment of HER2 positive metastatic breast cancer. Ruxolitinib (Jakafi) is an Food and Drug Administration (FDA) approved treatment for myelofibrosis (a disease of the bone marrow), but its safety and efficacy in breast cancer patients is not known. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer. The safety and efficacy of both treatments given in combination is not known. It is hypothesized that Ruxolitinib in combination with Trastuzumab will demonstrate efficacy in treating Metastatic HER2 Positive Breast Cancer subjects, and will have a tolerable safety profile in this patient population.
Timeline
- Start
- 2014-06
- Primary completion
- 2020-10-14
- Completion
- 2020-10-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 10 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 15 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 20 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 25 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |