Vinflunine vs alkylating agents in ABC

• Research type

  Research Study

• Full title

  A phase III trial of IV vinflunine versus an alkylating agent in patients with metastatic breast cancer previously treated with or resistant to an anthracycline, a taxane, an antimetabolite and a vinca-alkaloid.

• IRAS ID

  16232

• Contact name

  Martin Hogg

• Sponsor organisation

  Pierre Fabre Medicament/Institut de Recherche Pierre Fabre

• Eudract number

  2009-011118-47

• ISRCTN Number

  n/a

• Research summary

  This is an international Phase III study, with up to 170 centres worldwide. The study is open-labelled and patients will be randomised to receive either vfluine or an alkylating agent of physician choice for the treatment of cancer. Allocated treatments are: Vfluine at a dose of 280mg/mý by intravenous infusion on day 1 of a 21 day cycle of treatment. In addition patients will receive appropriate best supportive care (i.e. analgesia, biphosphonates, blood transfusions, nutritional support, palliative radiotherapy). Or: An alkylating agent which is available for use at the centre. Patients eligible for the study will be identified through the oncology out-patient department and MDT meeting of the participating centres. 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 wks. 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 4 to 6 cycles of treatment. For patients who withdraw due to disease progression further data will be collected every month for the first 6 months and then every 3 months until death. Patients who withdraw for any other reason will have data collected every 6 weeks until disease progression.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/13

• Date of REC Opinion

  24 Mar 2010

• REC opinion

  Further Information Favourable Opinion