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NCT01702571 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Kadcyla (Trastuzumab Emtansine) in Patients With HER2 Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment (NCT01702571)

Trial Description
This two-cohort, open-label, multicenter study will assess the safety and the efficacy of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior anti-HER2 and chemotherapy-based treatment. Patients in Cohort 1 will be drawn from the general patient population; Cohort 2 will include only asian patients. Patients in both cohorts will receive 3.6 mg/kg Kadcyla intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.

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

Study Data

  • Condition: Breast Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: III
  • Estimated Enrollment: 2220
  • Start: November 2012
  • Estimated Completion: July 2018
  • Last verified: July 2015

Study Schematic

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Last Editorial review: July 30, 2015
Information based on (NIH/NCI) and other sources.

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