A Randomized, Multicenter Open-Label Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens

Trial Profile

A Randomized, Multicenter Open-Label Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2015

At a glance

  • Drugs Lapatinib (Primary) ; Trastuzumab
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 14 Aug 2013 The European Commission granted an additional indication for lapatinib to be used in combination with trastuzumab based on overall survival results in the HER2+, HR- metastatic breast cancer population within this trial, according to GlaxoSmithKline.
    • 17 Dec 2010 Actual end date changed from 1 Jun 2007 to 1 Oct 2010 as reported by ClinicalTrials.gov.
    • 01 Feb 2010 Results published in the Journal of CLinical Oncology.
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