A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Timeline

Start

2018-08-02

Primary completion

2023-08-14

Completion

2023-08-14

Outcome

Missed primary endpoint

Stopped: “The study was terminated by the sponsor following interim analysis as the primary endpoint of iDFS crossed the pre-specified futility boundary of hazard ratio \> 1 in the Intent-to-Treat (ITT) population.”

paper the final stratified invasive disease-free survival hazard ratio was 1.11 (95% CI, 0.87-1.42; P = .38). PMID 39883436 ↗

paper The addition of the immune therapy drug atezolizumab to chemotherapy after surgery did not provide benefit among patients with triple-negative breast cancer who are at high risk of recurrent disease. PMID 39883436 ↗

Publications

• Ignatiadis M, Bailey A, McArthur H, El-Abed S, de Azambuja E, Metzger O, Chui SY, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger GG, Jassem J, Lee SC, Higgins M, Zarba J, Schmidt M, Gomez H, Guerrero Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch NE, Bajetta E, Ohno S, Im SA, Werutsky G, Gal-Yam EN, Gonzalez Farre X, Tseng LM, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron DA, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30;333(13):1150-60. doi: 10.1001/jama.2024.26886. Online ahead of print.
• Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Epirubicin	Small molecule	90 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications