Metastatic Breast Cancer (MBC) Clinical Trial
Official title:
A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00236899 -
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
|
Phase 3 | |
| Recruiting |
NCT06143553 -
Paclitaxel Polymeric Micelles for Injection Versus TPC on the Treatment of HER2-negative Metastatic Breast Cancer (MBC).
|
Phase 3 | |
| Active, not recruiting |
NCT02605486 -
Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
|
Phase 1/Phase 2 | |
| Completed |
NCT01471847 -
A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
|
Phase 1 | |
| Completed |
NCT02312622 -
Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
|
Phase 2 |