drugset / Trial / NCT02139358
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
Phase 1/2
Completed
15 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.
Timeline
- Start
- 2014-09-05
- Primary completion
- 2018-04-24
- Completion
- 2020-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 850 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |