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Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients (BEECH)
The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | COMPLETED |
| Enrolment | 148 |
| Start date | Wed Oct 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Oct 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Advanced or Metastatic Breast Cancer
- ER+ve Advanced or Metastatic Breast Cancer
Interventions
- AZD5363 when combined with weekly paclitaxel.
- AZD5363 when combined with weekly paclitaxel.
- AZD5363when combined with weekly paclitaxel.
- A placebo in combination with weekly paclitaxel.
Countries
France, Japan, Peru, United Kingdom, Mexico, South Korea, Canada, Bulgaria, Singapore, Spain, Czechia