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NCT01419197 (TH3RESA) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician’s Choice in Patients With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy (TH3RESA) (NCT01419197)

Trial Description
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in comparison with treatment of the physician’s choice in patients with metastatic or unresectable locally advanced/recurrent HER2-positive breast cancer. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician’s choice. Patients continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

This trial is sponsored by  F. Hoffmann-La Roche. [1]

Study Data

  • Condition: Breast Cancer
  • Interventions:
    • Drugs used in this trial
      • Ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.)
      • Treatment of physician’s choice
  • Phase: III
  • Enrollment: 602
  • Start: February 2011
  • Estimated Completion: June 2015
  • Last verified: April 2014

Study Schematic

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Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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