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A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients with HER2-positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients with Early Progressive Disease While Receiving T-DM1 Alone.

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Trial Profile

A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients with HER2-positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients with Early Progressive Disease While Receiving T-DM1 Alone.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Nov 2021

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At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Pertuzumab
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Adverse reactions
  • Sponsors Genentech

Most Recent Events

  • 07 Jan 2020 Results of an individual patient-level data pooled analysis of trials testing T-DM1 in the advanced setting investigating T-DM1-induced cardiotoxicity, with a focus on the incidence of CEs, clinical presentation of CEs, impact on treatment continuity, reversibility as well as in any potential risk factors that could aid in patient selection and follow-up published in the European Journal of Cancer
  • 22 Dec 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 28 Jan 2011 ImmunoGen added as company association

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