TACT2

Trial details

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 4,391 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).

To learn and understand more about your diagnosis, and the care and treatment you receive, we have asked your permission to access information in your NHS medical records about your health conditions, treatment, progress, and (in the event of your passing away for whatever reason) mortality information. To do this your NHS number and date of birth was securely shared by the PHE National Cancer Registration and Analysis Service (NCRAS) to allow your records to be located. Data supplied by NCRAS will relate to your cancer and care over time, and will be linked to the information obtained from your hospital as part of the trial. All the information shared with NCRAS will be governed by strict rules covering data protection and confidentiality. Find out more about how we will protect your information.

Clinical Coordinators: David Cameron (Chief Investigator)

• Peter Canney
• Peter Barrett-Lee

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: Jane Banerji - Trial Manager, [email protected]

ISRCTN: 68068041

Sponsors: Lothian Health Board and The Institute of Cancer Research

Funding: Cancer Research UK (CRUK/05/019), Roche, Amgen and Pfizer

Further information

Further information for potential participants

Patient Information Sheet

Patient Information Sheet Cardiac Sub study

Further information for healthcare professionals

Protocol

Protocol Cardiac Sub-Study

View TACT2 on the National Institute for Health Research website: NIHR - Be Part Of Research

Publications and presentations

Canney P, Coleman R, Morden J, Barrett-Lee P, Banerji J, Wardley A, Murray N, Laing R, Cameron D, Bliss J. TACT2 trial in early breast cancer (EBC): Differential rates of amenorrhea in postmenopausal women following adjuvant epirubicin (aE) followed by capecitabine (X) or CMF (CRUK/05/019). Eur. J. Cancer 2012;48(Suppl 1):S102 # 200

Bliss J, Canney P, Velikova G, Barrett-Lee P, Moyses H, McDermaid M, Banerji J, Gaunt C, Reynolds C, Agrawal R, Murray P, Clark P, Goodman A, Cameron D. TACT2 Randomised Adjuvant Trial in Early Breast Cancer (EBC): Tolerability and Toxicity of Standard 3 Weekly Epirubicin (E) Versus Accelerated Epirubicin (aE) Followed by Capecitabine (X) or CMF in 129 UK Hospitals (CRUK/05/019). Cancer Res. 2010;70(24 Suppl):#P5-10-07

Cameron D, Barrett-Lee P, Velikova G, Canney P, Moyses H, McDermaid M, Banerji J, Gaunt C, Reynolds C, Wardley A, Bowman A, Bertelli G, Murray N, Bliss J. TACT2 Randomised Adjuvant Trial in Early Breast Cancer (EBC): Tolerability and Toxicity of Standard 3 Weekly Epirubicin (E) Versus Accelerated Epirubicin (aE) in 129 UK Hospitals (4391 Patients) (CRUK/05/019). Cancer Res. 2010;70(24 Suppl):#P5-10-06

Johnson L, Cameron D, Barrett-Lee P, Canney P, Bliss JM. Improving adjuvant chemotherapy in breast cancer -- can we get more for less with TACT2? Clin Oncol (R.Coll.Radiol.) 2007;19(8):593-95

Johnson L, Barrett-Lee P, Bliss J, Cameron D, Canney P. TACT2: Trial of accelerated adjuvantchemotherapy with capecitabine in early breast cancer. BOA Annual Scientific Meeting 2004;16:S28 #P2.04