NCT03726879

A Study 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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered as per the schedule specified in the respective arm.
DRUG	Placebo	Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.
DRUG	Doxorubicin	Doxorubicin will be administered as per the schedule specified in the respective arm.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as per the schedule specified in the respective arm.
DRUG	Paclitaxel	Paclitaxel will be administered as per the schedule specified in the respective arm.
DRUG	Trastuzumab	Trastuzumab will be administered as per the schedule specified in the respective arm.
DRUG	Pertuzumab	Pertuzumab will be administered as per the schedule specified in the respective arm.
DRUG	Trastuzumab Emtansine	Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.

Timeline

• Start date: 2019-01-11
• Primary completion: 2021-02-05
• Completion: 2023-08-24
• First posted: 2018-11-01
• Last updated: 2024-11-05
• Results posted: 2022-03-25

Locations

76 sites across 12 countries: United States, Brazil, Canada, Czechia, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study