BIBW 2992 and Vinorelbine versus Trastuzumab and Vinorelbine.

• Research type

  Research Study

• Full 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.

• IRAS ID

  88646

• Contact name

  Hartmut Kresteleit

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2009-015476-98

• Clinicaltrials.gov Identifier

  NCT01125566

• Research summary

  The purpose of this study is to compare the efficacy and safety of BIBW 2992 in combination with vinorelbine intra venous chemotherapy with the efficacy of trestuzumab and vinorelbine intravenous chemotherapy as treatment in patients with HER2-overexprissing, metastatic breast cancer, who failed one prior trestuzumab (Herceptin©) treatment. This is an Open-label, randomised phase III study with randomisation of 2:1. 780 patients will be randomised and patients will receive continuous treatment in the absence of disease progression or adverse events.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/2013

• Date of REC Opinion

  20 Jan 2012

• REC opinion

  Further Information Favourable Opinion