A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy

Summary

This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Timeline

Start

2016-09-26

Primary completion

2017-12-11

Completion

2020-02-06

Outcome

Missed primary endpoint

registry Trastuzumab Emtansine + Placebo vs Trastuzumab Emtansine + Atezolizumab; p = 0.3332; Hazard Ratio (HR) 0.82 (95% CI 0.55 to 1.23); Log Rank NCT02924883 ↗

paper Addition of atezolizumab to trastuzumab emtansine did not show a clinically meaningful improvement in progression-free survival PMID 33002436 ↗

Publications

• Emens LA, Esteva FJ, Beresford M, Saura C, De Laurentiis M, Kim SB, Im SA, Wang Y, Salgado R, Mani A, Shah J, Lambertini C, Liu H, de Haas SL, Patre M, Loi S. Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial. Lancet Oncol. 2020 Oct;21(10):1283-1295. doi: 10.1016/S1470-2045(20)30465-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Trastuzumab emtansine	Other / unclassified	3.6 mg/kg	Intravenous

Indications