drugset / Trial / NCT01132664
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.
Timeline
- Start
- 2010-05
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buparlisib | Small molecule | — | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |