Trials / Completed
CompletedNCT04177108
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions. |
| DRUG | Ipatasertib | Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions. |
| DRUG | Paclitaxel | Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions. |
| DRUG | Placebo for Atezolizumab | Placebo was administered as per the dosage regimen mentioned in arm descriptions. |
| DRUG | Placebo for Ipatasertib | Placebo was administered as per the dosage regimen mentioned in arm descriptions. |
Timeline
- Start date
- 2019-11-25
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2019-11-26
- Last updated
- 2024-03-27
- Results posted
- 2024-03-27
Locations
182 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Czechia, Denmark, Finland, France, Greece, Hong Kong, India, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04177108. Inclusion in this directory is not an endorsement.