aTTom-Extended Version 1.0, 15th March 2016

• Research type

  Research Study

• Full title

  aTTom-Extended: Extended follow-up of patients enrolled in the Adjuvant Tamoxifen Treatment - Offer More? (aTTom) trial

• IRAS ID

  191732

• Contact name

  Daniel Rea

• Contact email

  d.w.rea@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  11 years, 7 months, 1 days

• Research summary

  The aim of the aTTom: adjuvant Tamoxifen Treatment offer more? Trial (MREC (1) 97/34, ISRCTN17222211) was to determine if taking tamoxifen for 10 years compared with the standard of 5 years improved overall survival and disease free survival. The preliminary analysis of the primary outcome measure was performed in 2013 and presented at the American Society for Clinical Oncology (ASCO) (http://meetinglibrary.asco.org/content/112995132). The result demonstrated that taking tamoxifen for 10 years is superior to 5 years in reducing breast cancer recurrence and, probably, mortality.
  However, as the reductions in breast cancer mortality only emerge after 10 years, even longer follow-up is needed to assess how large the benefits are and to monitor safety (incidence of new primary tumours, in particular endometrial cancer and non-cancer mortality.
  It is entirely possible that the incremental improvements will continue longer term. Therefore it is important that we continue to follow up these patients to ensure the full impact on overall survival is understood. We therefore seek approval for aTTom Extended study, to continue the follow up of the participants enrolled into the aTTom clinical trial (MREC (01)97/34) obtaining mortality data from the Office of National Statistics. Additionally we seek approval to conduct a translational sub study to validate diagnostic tests using tissue blocks from the patients previous randomised into the aTTom clinical trial (Trans aTTom - Sub study of aTTom Extended).

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  16/EM/0142

• Date of REC Opinion

  3 May 2016

• REC opinion

  Further Information Favourable Opinion