Phase II TKI258 Study in metastatic HER2- breast cancer

• Research type

  Research Study

• Full title

  A multi-center, open label Phase II trial of TKI258 in FGFR1 amplified and non-amplified metastatic HER2 negative breast cancer

• IRAS ID

  25845

• Contact name

  Nicholas Turner

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-006430-10

• Clinicaltrials.gov Identifier

  NCT00958971

• Research summary

  The purpose of this trial is to determine the effectiveness and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status. All patients in the study will be treated with TKI258. This trial is sponsored by the pharmaceutical company named Novartis.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/89

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Favourable Opinion