drugset / Trial / 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

Phase 3 Completed 454 enrolled Hoffmann-La Roche Chugai Pharmaceutical · collab

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2019-01-11
Primary completion: 2021-02-05
Completion: 2023-08-24

Outcome

Missed primary endpoint

registry Atezolizumab +ddAC-PacHP vs Placebo +ddAC-PacHP; p = 0.1846; Odds Ratio (OR) 0.67 (95% CI 0.37 to 1.21) NCT03726879 ↗

registry Atezolizumab +ddAC-PacHP vs Placebo +ddAC-PacHP; p = 0.9551; Odds Ratio (OR) 0.99 (95% CI 0.67 to 1.46) NCT03726879 ↗

paper did not increase pCR rates versus placebo in the ITT or PD-L1-positive populations. PMID 35763704 ↗

Publications

Huober J, Barrios CH, Niikura N, Jarzab M, Chang YC, Huggins-Puhalla SL, Pedrini J, Zhukova L, Graupner V, Eiger D, Henschel V, Gochitashvili N, Lambertini C, Restuccia E, Zhang H; IMpassion050 Trial Investigators. Atezolizumab With Neoadjuvant Anti-Human Epidermal Growth Factor Receptor 2 Therapy and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Primary Results of the Randomized Phase III IMpassion050 Trial. J Clin Oncol. 2022 Sep 1;40(25):2946-2956. doi: 10.1200/JCO.21.02772. Epub 2022 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	—
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Trastuzumab emtansine	Other / unclassified	3.6 mg/kg	Intravenous