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NCT00943670 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression (NCT00943670)

Trial Description
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of Trastuzumab Emtansine (T-DM1, Kadcyla®; Genentech, Inc.) on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and to make preliminary assessments regarding the safety, tolerability, and efficacy of combined T-DM1 and Pertuzumab (Perjeta®; Genentech, Inc.) in patients with early disease progression.

The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia’s correction; the QTcB interval is the QT interval as calculated using Bazett’s correction.

This trial is sponsored by Genentech. [1]

Study Data

  • Condition: Metastatic Breast Cancer
  • Interventions:
  • Phase: II
  • Enrollment: 51
  • Study Start Date: July 2009
  • Study Completion Date: August 2011
  • Last verified: May 2013

Study Schematic

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Last Editorial review: July 27, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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