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
| ISRCTN | ISRCTN79718493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79718493 |
| ClinicalTrials.gov (NCT) | NCT00033683 |
| Protocol serial number | N/A |
| Sponsor | Sponsor not defined - Record supplied by Institute of Cancer Research |
| Funder | Cancer Research UK (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 17/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Deborah Coward
Scientific
Scientific
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton, Surrey
SM2 5NG
United Kingdom
| Phone | +44 (0)208 722 4299 |
|---|---|
| Tact-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 acronym | TACT |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Control Arm A: 5- Fluorouracil (5-FU) (600 mg/m^2 intravenous [iv] bolus), Epirubicin (60 mg/m^2 iv bolus), Cyclophosphamide (600 mg/m^2 iv bolus) x eight cycles at three weekly intervals. Control Arm B: Epirubicin (100 mg/m^2 iv bolus) x four cycles at three weekly intervals followed by Cyclophosphamide 100 mg/m^2 orally days one to 14 OR 600 mg/m^2 iv bolus days one, eight, Methotrexate 40 mg/m^2 iv bolus days one, eight, 5-FU 600 mg/m^2 iv bolus days one, eight x four cycles at four weekly intervals. Study Arm: Docetaxel (100 mg/m^2) as one hour infusion for four cycles at three weekly intervals. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and cyclophosphamide, methotrexate and 5-fluorouracil (CMF) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 3340 |
| Key inclusion criteria | 1. Patients with operable histologically confirmed completely resected invasive breast cancer for whom adjuvant chemotherapy is indicated 2. No clinical or radiological evidence of locoregional or metastatic disease based on standard staging procedures at local centres 3. World Health Organisation (WHO) performance status of zero or one 4. Chemotherapy to start within eight weeks from date of definitive surgery 5. Aged over 18 years (no upper age limit) 6. Hormone receptor status to be determined prior to randomisation 7. Adequate renal, hepatic and bone marrow function 8. Signed written informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 20/05/2001 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/05/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
