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A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin) and Docetaxel (Taxotere) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Trial Profile

A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin) and Docetaxel (Taxotere) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Docetaxel; Trastuzumab
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer
  • Focus Therapeutic Use
  • Sponsors Roche

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
  • 17 May 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 04 Feb 2013 Results published in the Journal of Clinical Oncology.

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