drugset / Trial / NCT01471847
A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2+ breast cancer. The first part (phase Ib) will investigate the MTD/ RP2D of the combination therapy of BEZ235 BID and weekly trastuzumab using a Bayesian model. Once MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly trastuzumab plus BEZ235 BID compared to capecitabine and lapatinib.
Timeline
- Start
- 2012-02
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Subject | Dactolisib | Small molecule | — | Oral |
| Comparator | Lapatinib | Small molecule | 1250 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | — |