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| [ Print-friendly version ] |
| Trial of Accelerated Adjuvant Chemotherapy with Capecitabine in Early Breast Cancer |
| ISRCTN | ISRCTN68068041 |
| ClinicalTrials.gov identifier | NCT00301925 |
| Public title | Trial of Accelerated Adjuvant Chemotherapy with Capecitabine in Early Breast Cancer |
| Scientific title | |
| Acronym | TACT2 |
| Serial number at source | N/A |
| Study hypothesis |
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. Please note that as of 19/11/2008 the anticipated end date of this trial was extended to the 5th December 2008. The initial anticipated end date was 15/10/2008. Please note, as of 28/09/2011 this trial is closed to recruitment with ongoing follow up. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Protocol TACT2: Version 1d approved on the 23rd September 2005, UK Ethics Committee MREC ref: 04/MRE00/88. Version 3 approved on the 13th May 2008.
Added 28/09/2011: Current protocol, version 5 approved July 2009. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Early breast cancer |
| Participants - inclusion criteria |
Patients with early breast cancer for whom treatment with anthracycline chemotherapy is indicated.
1. Histological diagnosis of invasive breast carcinoma 2. Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection). 3. Early stage disease (T0-3 N0-2 M0)with no evidence of distant metastases on routine staging 4. Definite indication for adjuvant chemotherapy 5. ECOG status 0 or 1 6. Aged over 18 years (no upper age limit) 7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function ie: 7.1 Hb > 9g/dL; WBC > 3 ´ 109/L; platelets > 100 x 109/L 7.2 Bilirubin within normal range (unless known Gilbert’s disease) 7.3 AST/ALT = 1.5 x Upper limit of normal (ULN) 7.4 Albumen within normal range 7.5 Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min 7.6 No active, uncontrolled infection 8. Signed TACT2 trial consent form 9. Randomisation within 8 weeks of surgery, but ideally within 1 month 10. No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except: 10.1 Previous radiotherapy for basal cell carcinoma 10.2 Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry 11. No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection. 12. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active 13. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up |
| Participants - exclusion criteria |
1. Only cytological proof of malignancy
2. No evidence of invasive breast cancer 3. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS is allowed) 4. Locally advanced breast cancer (T4 and/or N3 disease) 5. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy 6. Patients with positive surgical margins unless either: 6.1 Deep surgical margin involvement following full thickness resection 6.2 Non-invasive cancer at surgical margins and a decision to perform mastectomy on completion of chemotherapy has already been made 7. Patients not able or willing to give informed consent 8. Patients known not to be available for a minimum of 5 years’ follow-up 9. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV 10. Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medication and/or resulting in restricted physical activity) 11. Patients with a history of significant renal impairment or disease 12. Simultaneous participation in the active intervention phase of another treatment trial 13. Being approached and recruited into the active intervention phase of another treatment trial two months before or after recruitment into TACT2 |
| Anticipated start date | 15/10/2005 |
| Anticipated end date | 05/12/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 4400 patients (both male and female). Recruitment now closed. |
| Interventions |
Epirubicin followed by cyclophosphamide, methotrexate and 5-fluorouracil (5-FU) (E-CMF)
Accelerated E-CMF Epi-capecitabine Accelerated epi-capecitabine |
| Primary outcome measure(s) | Disease-free survival (DFS) |
| Secondary outcome measure(s) | Overall survival (OS), distant disease-free survival (DDFS), tolerability (including Serious Adverse Events (SAE)), dose-intensity and toxicity, Detailed Toxicity and Quality of Life in the subset of patients studied. |
| Sources of funding |
1. Cancer Research UK (CRUK) (UK) (ref: C1491/A4858)
2. Hoffman La-Roche (UK) 3. Amgen Ltd (UK) 4. Pfizer Pharmaceuticals (UK) |
| Trial website | http://www.ncrn.org.uk/ |
| Publications | |
| Contact name | Prof David Cameron |
| Address |
Edinburgh Research Centre,
Western Genral Hospital, Crewe Road South, |
| City/town | Edinburgh |
| Zip/Postcode | EH4 2XR |
| Country | United Kingdom |
| Sponsor | The Institute of Cancer Research (UK) |
| Address |
C/O Prof Alan Ashworth (CEO Institute of Cancer Research)
The Institute of Cancer Research 123 Brompton Road |
| City/town | London |
| Zip/Postcode | SW7 3RP |
| Country | United Kingdom |
| Date applied | 19/07/2004 |
| Last edited | 28/09/2011 |
| Date ISRCTN assigned | 10/09/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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