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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. |
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TACT2
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Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer
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Topic
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Cancer
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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68068041
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EudraCT
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2004-000066-13
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MREC N° |
04/MRE00/88
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UKCRN ID |
1311
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WHO ID
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Research Summary
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A randomised, phase III clinical trial with a 2 x 2 factorial design addressing two hypotheses:
1. That accelerating Epirubicin will improve the efficacy of the sequential schedules (based originally on the NEAT epirubicin/CMF schedule).
2. That the substitution of CMF by Capecitabine will not be detrimental to patient outcome but will offer advantages in Quality of Life and/or toxicity.
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Study Type |
Both
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Design Type |
Treatment, Not specified
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Disease(s) |
Breast
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Phase |
III
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Current Status
| Closed - in follow-up |
| Closure Date | 04/12/2008 |
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Sample Size
| 4400 |
| Accrual to Date |
 | 97% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| Unknown (also active in England and Scotland and Northern Ireland and Wales) |
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Main Inclusion Criteria
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• Histological diagnosis of invasive breast carcinoma
• Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection).
• Early stage disease ( T0-3 N0-2 M0) without clinical suspicion/evidence of distant metastases on routine staging
• Definite indication for adjuvant chemotherapy
• ECOG status 0 or 1
• Aged over 18 years (no upper age limit)
• Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function i.e.
o Hb > 9g/dL; WBC > 3 ? 109/L; platelets > 100 x 109/L
o Bilirubin within normal range (unless known Gilbert’s disease)
o AST/ALT = 1.5 x Upper limit of normal (ULN)
o Albumen within normal range
o Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min
o No active, uncontrolled infection
• Signed TACT2 trial consent form
• Randomisation within 8 weeks of surgery, but ideally within 1 month
• No previous chemotherapy, hormonal
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Main Exclusion Criteria
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• Only cytological proof of malignancy
• No evidence of invasive breast cancer
• Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS is allowed)
• Locally advanced breast cancer (T4 and/or N3 disease)
• Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy
• Patients with positive surgical margins unless either
o Deep surgical margin involvement following full thickness resection
o Non-invasive cancer at surgical margins and a decision to perform mastectomy on completion of chemotherapy has already been made
• Patients not able or willing to give informed consent
• Patients known not to be available for a minimum of 5 years’ follow-up
• Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV
• Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medicati
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Chief Investigator(s)
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| Prof Judith Bliss | Prof David Cameron |
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Further details, please contact
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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
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Funder(s) |
Amgen Ltd
Cancer Research UK
Pfizer
Roche Ltd
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Sponsor(s) |
Lothian Health Board
Institute of Cancer Research
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