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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
TACT

A randomised trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or Epirubicin and CMF (Epi-CMF) vs FEC followed by sequential docetaxel as adjuvant treatment for women with early breast cancer


Topic
Cancer
Portfolio Eligibility
Funded by UKCRC partner
ISRCTN 79718493
EudraCT
MREC N° 20/05/2001
UKCRN ID 770
WHO ID
Research Summary
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 as adjuvant treatment for women with early breast cancer
Study Type Interventional
Design Type Treatment
Disease(s) Breast
Phase III
Current Status Closed - in follow-up
Closure Date16/06/2003
Sample Size 3340
Accrual to Date
124%
Geographical Scope UK Multi-Centre
Lead Country Unknown (also active in England and Scotland and Wales)
Main Inclusion Criteria
Patients with operable histologically confirmed completely resected invasive breast cancer for whom adjuvant chemotherapy is indicated.
No clinical or radiological evidence of locoregional or metastatic disease based on standard staging procedures at local centres.
WHO performance status of 0 or 1.
Chemotherapy to start within < 8 weeks from date of definitive surgery.
Aged > 18 years (no upper age limit).
Hormone receptor status to be determined prior to randomisation.
Adequate renal, hepatic and bone marrow function.
Signed written informed consent.
Main Exclusion Criteria
not specified
Chief Investigator(s)
Prof Peter Barrett-LeeDr Paul Ellis
Further details, please contact
Ms Jane Banerji

Institute of Cancer Research
Clinical Trials & Statistics Unit (ICR-CTSU) Section of Clinical Trials Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
UNITED KINGDOM

Tel: 0208 722 4299
Jane.Banerji@icr.ac.uk
Funder(s) Pharmacia and Upjohn
Cancer Research UK
Sanofi-Aventis
Roche Ltd
Sponsor(s) Institute of Cancer Research




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