Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer.

Trial Profile

Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer.

Completed
Phase of Trial: Phase II

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Lapatinib (Primary) ; Trastuzumab (Primary) ; Cyclophosphamide; Epirubicin; Fluorouracil; Paclitaxel
  • Indications Early breast cancer
  • Focus Pharmacogenomic; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 12 Oct 2017 Results (n=213) of study developing and validating a tool to predict response by assessing association between pathological response and early changes in tumor infiltrating lymphocytes using patient data from NCT01973660 and NCT00524303 trials published in the Annals of Oncology
    • 07 Mar 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 07 Jun 2011 Preliminary efficacy results presented at the 47th Annual Meeting of the American Society of Clinical Oncology.
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