A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Active Comparator: Arm A: Placebo + Trastuzumab Emtansine
  Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.
• Experimental: Arm B: Atezolizumab + Trastuzumab Emtansine
  Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Geprüfte Regime

• Atezolizumab (Tecentriq, RO5541267, MPDL3280A):
  Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
• Trastuzumab Emtansine (Kadcyla, T-DM1, RO5304020):
  Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
• Placebo:
  Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
• Trastuzumab (Herceptin):
  Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.

Quelle: ClinicalTrials.gov