MO22982 PrefHer Study Version 1.0 dated 30th May 2011

• Research type

  Research Study

• Full title

  A Randomised, multi-centre cross-over study to evaluate patient preference and Health Care Professional (HCP) satisfaction with subcutaneous administration of trastuzumab in HER2 -positive early breast cancer (EBC)

• IRAS ID

  72738

• Contact name

  Peter Barratt- Lee

• Sponsor organisation

  F Hoffman La Roche

• Eudract number

  2010-024099-25

• ISRCTN Number

  Unknown

• Research summary

  This is a study to look at both patient and doctor preference for the way that Herceptin© (trastuzumab) is given for the treatment of HER2 positive early breast cancer. The trastuzumab will be given as a drip into a vein over 30 - 90 minutes every 3 weeks, or as an injection under the skin given over 5 minutes via a single use injector device every 3 weeks.Patients will either receive the first 4 doses of trastuzumab as a drip, followed by 4 doses as an injection under the skin OR will receive their first 4 doses as an injection under the skin followed by 4 doses as a drip. All patients will be planned to receive a further 18 doses of trastuzumab (total 22 doses) as a drip.The patients will be asked questions which treatment they might prefer by a telephone interview prior to their first dose of treatment, then again after the eighth dose, they will be asked which treatment they actually preferred.The doctor and trial nurse will also be asked to complete a questionnaire when 5 patients from their hospital have been given their first 8 doses of treatment. The questions will be about how satisfied they are with the different treatments and to see if there is a difference in the time taken to give the treatment.Patients will have exactly the same treatment if they were not part of the study, except for the 4 doses of treatment given by the injector device and the need to have 2 telephone interviews

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1136

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion