Clinical Trial: NCT03379428
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | US Oncology Research |
| Information Provided By: | US Oncology Research |
| Last Update Posted: | 2024-12-06 |
Study Overview
Brief 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).
Official Title
Conditions
Intervention / Treatment
- Drug: Trastuzumab
- Drug: Ibrutinib 560 mg
- Drug: Ibrutinib 840 mg
- Drug: Ibrutinib 420 mg
Other Study ID Numbers
- 14059
- 14-059
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | US Oncology Research |
| Information Provided By: | US Oncology Research |
| Last Update Posted: | 2024-12-06 |
Study Overview
Brief 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).
Official Title
Conditions
Intervention / Treatment
- Drug: Trastuzumab
- Drug: Ibrutinib 560 mg
- Drug: Ibrutinib 840 mg
- Drug: Ibrutinib 420 mg
Other Study ID Numbers
- 14059
- 14-059