A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

Summary

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Timeline

Start

2018-01-11

Primary completion

2024-10-23

Completion

2024-10-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo + Chemotherapy vs Atezolizumab + Chemotherapy; p = 0.5891; Hazard Ratio (HR) 0.93 (95% CI 0.73 to 1.20); Log Rank NCT03371017 ↗

registry analysis (superiority test); Placebo + Chemotherapy vs Atezolizumab + Chemotherapy; p = 0.6139; Hazard Ratio (HR) 0.94 (95% CI 0.76 to 1.18); Log Rank NCT03371017 ↗

paper OS, which is dismal in patients with TNBC relapsing within <12 months, was not improved by adding atezolizumab to chemotherapy. PMID 38755096 ↗

Publications

• Dent R, Andre F, Goncalves A, Martin M, Schmid P, Schutz F, Kummel S, Swain SM, Bilici A, Loirat D, Villalobos Valencia R, Im SA, Park YH, De Laurentis M, Colleoni M, Guarneri V, Bianchini G, Li H, Kirchmayer Machackova Z, Mouta J, Deurloo R, Gan X, Fan M, Mani A, Swat A, Cortes J. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol. 2024 Jul;35(7):630-642. doi: 10.1016/j.annonc.2024.04.001. Epub 2024 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Carboplatin	Small molecule	2 unknown	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications