Value through Innovation27 July 2016

Clinical Study Results

  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1170.2
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A phase I biodistribution study with 186 Re-labelled humanised monoclonal antibody BIWA 4, in patients with adenocarcinoma of the breast.

    Study Document Trial synopsis 1170.2_CO english
  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1191.1
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I single dose escalation study of bivatuzumab mertansine administered intravenously in female patients with CD44v6 positive metastatic breast cancer with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1191.1 english
  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1191.3
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I dose escalation study of bivatuzumab mertansine administered intravenously once per week for three weeks in female patients with CD44v6 positive recurrent or metastatic breast cancer with repeated administration courses in patients with clinical benefit

    Study Document Trial synopsis 1191.3 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.5
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II study of BIBW 2992 added to letrozole in patients with ER+ve   hormone refractory metastatic breast cancer progressing on letrozole

    Study Document Trial synopsis 1200.5_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.10
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open-label phase II trial to assess the efficacy and safety of a once daily oral   dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen

    Study Document Trial synopsis 1200.10_DS_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.11
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy

    Study Document Trial synopsis 1200.11_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.44
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A neoadjuvant, randomized, open-label Phase II trial of BIBW 2992 versus  trastuzumab versus lapatinib in patients with locally advanced HER2 –positive  breast cancer

    Study Document Trial synopsis 1200.44_DS_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.68
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I open label trial to assess safety of BIBW 2992 in combination with Herceptin® in patients with HER2-positive advanced breast cancer

    Study Document Trial synopsis 1200.68_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.75
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment

    Study Document Trial synopsis 1200.75_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.67
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 3; Randomised phase II study of afatinib alone or in combination with vinorelbine versus investigator’s choice of treatment in patients with HER2-positive breast cancer with progressive brain metastases after trastuzumab and/or lapatinib based therapy

    Study Document Trial synopsis 1200.67_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.89
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label, phase II trial of afatinib with or without vinorelbine for the treatment of HER2-overexpressing inflammatory breast cancer

    Study Document Trial snyopsis 1200.89_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.134
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I trial of afatinib in combination with 3 weekly trastuzumab in patients with tumours overexpressing HER2. Once the MTD of afatinib with 3 weekly trastuzumab was established the safety of this dose will be assessed also in combination with weekly trastuzumab

    Study Document Trial statement 1200.134 english Trial synopsis 1200.134 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.98
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 2: An open-label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2- targeted treatment in the neoadjuvant and/or adjuvant treatment setting

    Study Document Trial synopsis 1200.98 english

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