drugset / Trial / NCT03379428
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer
Phase 1/2
Active not recruiting
34 enrolled
US Oncology Research
AbbVie · collabPharmacyclics LLC. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).
Timeline
- Start
- 2017-11-29
- Primary completion
- 2025-01
- Completion
- 2025-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Ibrutinib | Small molecule | 840 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |