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A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

NCT04177108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2024-03-27

Study results available
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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

  • Triple-Negative Breast Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177108 on ClinicalTrials.gov