KATE3 : A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

Trial Identifiers

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• NCT04740918
• MO42319, CT1345

Scientific Title

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a double-blind, randomised parallel assignment trial with experimental and active comparator arms. Participants in the active comparator arm will receive a placebo, followed by 3.6 milligrams per kilogram (mg/kg) of intravenous (IV) trastuzumab emtansine. Participants in the Experimental arm will receive 1200 mg IV Atezolizumab followed by 3.6 mg/kg IV trastuzumab emtansine. All participants will receive the above treatments on Day 1, Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.