CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 454 enrolled
Drug / intervention
Atezolizumab +7 moredrug
Likely dose
Trastuzumab Emtansine 3.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03726879
NCT03726879Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

Hoffmann-La Roche·interventional·Posted Nov 1, 2018·Updated Nov 5, 2024

In Brief

A Phase 3 clinical trial evaluating Atezolizumab, Placebo, and 6 other interventions for Breast Cancer. Completed, enrolled 454 participants across 76 sites in 12 countries.

Detailed Summary

This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBrazil, Canada, Czechia, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, United States
CollaboratorsChugai Pharmaceutical

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 1, 2018
Enrollment StartJan 11, 2019
Primary CompletionFeb 5, 2021
Study CompletionAug 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.7 years ago

Interventions

Atezolizumabdrug

Atezolizumab will be administered as per the schedule specified in the respective arm.

Placebodrug

Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.

Doxorubicindrug

Doxorubicin will be administered as per the schedule specified in the respective arm.

Cyclophosphamidedrug

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Paclitaxeldrug

Paclitaxel will be administered as per the schedule specified in the respective arm.

Trastuzumabdrug

Trastuzumab will be administered as per the schedule specified in the respective arm.

Pertuzumabdrug

Pertuzumab will be administered as per the schedule specified in the respective arm.

Trastuzumab Emtansinedrug

Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.