A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.