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TACT

A randomised trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF) versus FEC followed by sequential docetaxel in women with early breast cancer.

Disease site: Breast cancer

Treatment modality: Chemotherapy

Status: In active follow-up

Trial details

The TACT trial is a randomised trial of standard anthracycline-based chemotherapy (fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF)) versus FEC followed by sequential docetaxel in women with early breast cancer.

4,162 patients were recruited between February 2001 and June 2003 from 103 UK centres and 1 Belgian centre. Patients were randomised following written informed consent. Patient assessment of quality of life (QOL) and a health economic analysis formed an integral part of the trial. The QOL study was conducted in a sub-set of centres. Tumour tissue was collected prospectively for subsequent biological studies, and blood DNA was requested from all patients.

Trial results were presented at the San Antonio Breast Cancer Symposium in December 2007 when 90% of the predefined number of events had been reported. The results of the trial were published in the Lancet (Ellis et al., 2009). Long term follow up is ongoing.

Chief Investigator: Professor Peter-Barrett Lee/Dr Paul Ellis

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: tact-icrctsu@icr.ac.uk

ISRCTN: 79718493

Sponsor: Guy’s and St Thomas’ Hospital

Funding: Cancer Research UK (CRUK/01/001), Sanofi-Aventis

Publications and presentations

Over 20 papers arising from the TACT trial have been published to date, including:

Hall E, Johnson L, Atkins N, Waters R, Barrett-Lee P, Ellis P, Cameron D, Bliss J, Hopwood P, on behalf of the TACT Trial Management Group. Cross-sectional study of Quality of Life (QL) 6 years after start of treatment in the UK Taxotere as Adjuvant Chemotherapy Trial (TACT; CRUK01/001). Eur J Cancer Supplements 2010;8(Suppl 3):184 #430

Ellis P, Barrett-Lee P, Johnson L, Cameron D, Wardley A, O'Reilly S, Verrill M, Smith I, Yarnold J, Coleman R, Earl H, Canney P, Twelves C, Poole C, Bloomfield D, Hopwood P, Johnston S, Dowsett M, Bartlett JM, Ellis I, Peckitt C, Hall E, Bliss JM. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. Lancet 2009;373(9676):1681-92

Barrett-Lee P, Bliss JM, Wardley A, Verrill M, O'Reilly S, Smith I, Johnson L, Peckitt C, A'Hern RP, Ellis P, on behalf of the TACT Trial Management Group. UK TACT trial results - Does everyone need adjuvant taxanes? Eur J Cancer Supplements 2008;6(7):47

Ellis PA, Barrett-Lee PJ, Bloomfield D, Cameron DA, Hall E, Johnson L, Johnston SRD, Bliss JM. Preliminary results of the UK Taxotere as Adjuvant Chemotherapy (TACT) Trial. Br Canc Res & Treatment 2007;106(Suppl 1):S21 #78

Johnson L, Bliss J, Ellis P, Barrett-Lee P, Johnston S. Blood samples for biological research - acceptance rate within the TACT Trials. NCRI National Cancer Conference; 2005; Birmingham.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.

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