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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

NCT03726879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2024-11-05

Study results available
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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

Interventions

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.

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
2019-01-11
Primary Completion
2021-02-05
Completion
2023-08-24
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03726879 on ClinicalTrials.gov