TACT2

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: In active follow-up

The primary aim of the trial is to assess whether accelerating the administration of adjuvant Epirubicin, when given before CMF or Capecitabine, will improve its efficacy, and to evaluate whether the use of oral Capecitabine instead of CMF (after Epirubicin) will be at least as effective as CMF and less toxic. The secondary aim is to evaluate any benefit in terms of toxicity (including serious adverse events, dose-intensity and tolerability), with a detailed evaluation of toxicity and Quality of Life in a sub-set of patients. Biological sub-studies are running in parallel to the main trial and health economic data will also be collected to determine the true costs of using Capecitabine instead of CMF and accelerated treatment. Recruitment started in December 2005 and closed to recruitment on 5 December 2008 with accrual of 4391 patients.

The trial is coordinated by the Institute of Cancer Research in collaboration with the Information and Statistics Division, (Edinburgh), Clinical Trials & Research Unit, (Leeds) and CR UK Clinical Trials Unit, (Birmingham).

Clinical Coordinators: David Cameron (Chief Investigator)

• Peter Canney
• Peter Barrett-Lee

Sponsor: Co-sponsored by Lothian Health Board and The Institute of Cancer Research

Source of funding: Administration of the trial is funded by Cancer Research UK, supported by unrestricted educational grants from Roche, Amgen and Pfizer.

ISRCTN: 68068041