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A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 139 |
| Start date | Tue Feb 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Mar 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Breast Cancer
Interventions
- Ipatasertib
- Paclitaxel
- Atezolizumab
- Nab-Paclitaxel
- AC
Countries
France, United Kingdom, Australia, United States, Spain