Vinflunine + capecitabine vs capecitabine alone in ABC

• Research type

  Research Study

• Full title

  A phase III trial of vinflunine + capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.

• IRAS ID

  3753

• Contact name

  Mary O'Brien

• Sponsor organisation

  Institut de Recherche Pierre Fabre

• Eudract number

  2008-004171-21

• ISRCTN Number

  n/a

• Research summary

  This is an international Phase III study, with up to 120 centres worldwide. The study is open-labelled and patients will be randomised to receive either vfluine and capecitabine or capecitabine alone for the treatment of metastatic breast cancer. Allocated treatments are: Arm A Day 1 - vfluine at a dose of 280mg/mgý by intravenous infusion Day 1-Day 14 - capecitabine at a dose of 825mg/mgý twice a day orally Day 15-Day 21 - no treatment Arm B Day 1-Day 14 - capecitabine at a dose of 1250mg/mgý twice a day orally Day 15-Day 21 - no treatment Patients eligible for the study will be identified through the oncology out-patient department and MDT of the participating centre. Patients will be given the Patient Information Sheet to read and discuss before signing a consent form. A full medical history will be recorded. Assessment of the current extent of the patients?? disease will be made by radiological scanning. Haematology and biochemistry assessment will be made prior to the first administration of treatment. Information concerning concomitant medications and adverse events will be collected before each cycle of treatment. Haematological and biochemistry assessments will be repeated during each cycle. Radiological scanning, to assess treatment response, will be performed every 6 weeks. Patients will receive at least 2 cycles of treatment unless there is early disease progression or an unacceptable toxicity occurs. Patients with responding or stable disease will continue with study treatment until disease progression, unacceptable toxicity or the patient states that she wishes to withdraw from the study. It is expected that a patient will receive 6 to 8 cycles before stopping treatment. For patients who withdraw from the study due to disease progression further data will be collected every 6 months until death. Those patients who are withdrawn for any other reason will have data collected every 6 wks until progression, then 6 monthly until death.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/66

• Date of REC Opinion

  13 Aug 2009

• REC opinion

  Further Information Favourable Opinion