1200.98 BIBW 2992 in metastatic HER2 over-expressing breast cancer

• Research type

  Research Study

• Full title

  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

• IRAS ID

  66823

• Contact name

  Tamas Hickish

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2010-021945-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to study the efficacy and safety of BIBW 2992 alone and in combination with either paclitaxel or vinorelbine chemotherapy given weekly in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant and/or adjuvant setting. Patients will initially undergo a 2 week screening period during which time their eligibility will be confirmed. Eligible patients will receive 40 mg/day BIBW 2992 in 3-weekly treatment courses until progression of disease. In the event of treatment-related adverse events, the dose of BIBW 2992 will be reduced according to a specific dose reduction scheme. Patients showing disease progression on BIBW 2992 alone will then receive chemotherapy, i.e. paclitaxel or vinorelbine weekly, as decided by their study doctor, which will in addition to BIBW 2992. The study will be stopped early to minimise the number of patients treated if BIBW 2992 was shown to be ineffective. All patients will attend an End of Treatment Visit (EOT) when they discontinue the study treatment permanently. Patients will have a follow-up visit 28 days after the EOT Visit. Following this, patients who still have not experienced disease progression and not started further treatment, will have further follow- up visits every 6 weeks until disease progression or start of further treatment. The end of the study is when the last patient entered has either experienced a second disease progression or started further treatment.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/H0502/12

• Date of REC Opinion

  18 Feb 2011

• REC opinion

  Further Information Favourable Opinion