1200.89: Afatinib in Inflammatory Breast Cancer

• Research type

  Research Study

• Full title

  1200.89: An open label, phase II trial of afatinib with or without vinorelbine for the treatment of HER2-overexpressing Inflammatory Breast Cancer

• IRAS ID

  71700

• Eudract number

  2010-024454-10

• Clinicaltrials.gov Identifier

  01325428

• Research summary

  This is an open label study to investigate the efficacy and safety of afatinib alone and in combination with vinorelbine in patients with HER2-overexpressing locally advanced or metastatic inflammatory breast cancer. All eligible patients will receive daily afatinib until disease progression, and then they will receive daily afatinib in combination with weekly vinorelbine until further disease progression. There will also be exploratory analyses of biomarkers in tumour tissue and blood to assist in the development of predictive biomarkers of response and resistance to afatinib.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0762

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Further Information Favourable Opinion