Trial Profile
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.
Status:
Discontinued
Phase of Trial:
Phase I/II
Latest Information Update: 07 Nov 2021
Price :
$35
*
At a glance
- Drugs Dactolisib (Primary) ; Paclitaxel
- Indications Advanced breast cancer
- Focus Adverse reactions; Therapeutic Use
- Sponsors Novartis; Novartis Pharmaceuticals
- 10 Sep 2020 Number of arms has been increased from 1 to 2, with the addition of BEZ235 200 mg bid + paclitaxel 80 mg (phase lb) arm containing higher dose (200 mg) of BEZ235.
- 10 Sep 2020 Status changed from completed to discontinued. Reason the study was stopped: Study did not meet Phase Ib primary objective to establish the maximum tolerated dose/recommended dose for Phase II.
- 22 Jul 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.