BIBW 2992 and Herceptin® in HER-2 Positive Advanced Breast Cancer

• Research type

  Research Study

• Full title

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

• IRAS ID

  18582

• Sponsor organisation

  Boehringer Ingelheim Ltd.

• Eudract number

  2009-010003-89

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a Phase I open label study to assess the safety of BIBW 2992 and Herceptin© in patients with HER2-positive advanced breast cancer.The aim of the study is to evaluate the Maximum Tolerated Dose (MTD) of BIBW 2992 when given continuously (daily) with Herceptin© (weekly). Initial treatment will be 4 weeks which may be repeated in a 4 weekly schedule if appropriate.Differing doses of BIBW 2992 will be used in this study, starting at 20mg once daily. Herceptin© will be administered with a loading dose of 4mg/kg initially and thereafter at 2mg/kg once a week.Safety, pharmacokinetics and efficacy will be evaluated.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/86

• Date of REC Opinion

  3 Jun 2009

• REC opinion

  Favourable Opinion