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 number | NCT00033683 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/05/2001 |
| Overall study end date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 3340 |
| Participant 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 |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 20/05/2001 |
| Recruitment end date | 01/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Sponsor not defined - Record supplied by Institute of Cancer Research
Research organisation
Research organisation
c/o 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
| Website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
|---|
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 16/05/2009 | Yes | No |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
