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A multicentre, randomised, controlled, open-labelled trial of paclitaxel-containing chemotherapy (ATT) followed by CMF versus the same chemotherapy plus Herceptin in women with locally advanced breast cancer and HER2/C-ERBB-2 overexpression and amplification, with a parallel observational study of the same chemotherapy regimen alone, in patients with HER2 negative tumors (0 or 1+ by immunohistochemistry).

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Trial Profile

A multicentre, randomised, controlled, open-labelled trial of paclitaxel-containing chemotherapy (ATT) followed by CMF versus the same chemotherapy plus Herceptin in women with locally advanced breast cancer and HER2/C-ERBB-2 overexpression and amplification, with a parallel observational study of the same chemotherapy regimen alone, in patients with HER2 negative tumors (0 or 1+ by immunohistochemistry).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2014

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At a glance

  • Drugs Trastuzumab (Primary) ; Cyclophosphamide; Doxorubicin; Fluorouracil; Methotrexate; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; HER2 positive breast cancer
  • Focus Therapeutic Use
  • Acronyms NOAH
  • Sponsors Roche
  • Most Recent Events

    • 19 Mar 2014 Results published in the Lancet Oncology.
    • 04 Jun 2013 Results presented at the 49th Annual Meeting of the American Society of Clinical Oncology.
    • 16 Mar 2010 Planned number of patients (332) added as reported by ISRCTN: Current Controlled Trials.

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