| Source of record | UK Trials |
| ISRCTN | ISRCTN42625759 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BR3014 |
| Public title | National beast cancer study of Epirubicin plus CMF versus classical CMF Adjuvant Therapy |
| Scientific title |
|
| Acronym | NEAT |
| Disease/condition/study domain | Breast |
| Study hypothesis | In women with early breast cancer, adjuvant combination chemotherapy which schedules 4 cycles of epirubicin, followed by 4 cycles of classical CMF, is significantly superior to classical CMF for 6 cycles, in terms of disease-free and overall survival. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological diagnosis of invasive breast cancer
2. Clinically early stage disease
3. Definitive surgery (either wide local excision or mastectomy) to the breast with complete excision of tumour
4. In the opinion of the clinician there is a definite indication for adjuvant chemotherapy, or the patient has been randomised to receive chemotherapy in the ABC study
5. Fit to receive chemotherapy in either of the two arms
6. No previous radiotherapy or chemotherapy
7. Adequate renal, hepatic and bone marrow function
8. Randomisation within 6 weeks of surgery, ideally within 1 month
9. No previous malignancy except, basal cell carcinoma or in situ carcinoma of the cervix |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 30/04/1996 |
| Anticipated end date | 31/07/2001 |
| Status of trial | Completed |
| Target number of participants | Target: 2000 patients. Recruited: 2028 |
| Interventions | 1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for six cycles.
2. Group B: Chemotherapy, epirubicin repeated every 3 weeks for four cycles followed by CMF repeated every 3 weeks for four cycles. |
| Primary outcome measure(s) | 1. 5 year disease-free survival
2. 5 year overall survival |
| Secondary outcome measure(s) | 1. Acute toxicity comparison between the two study arms
2. Quality of life and limited health economic comparisons between the two study arms, in a subset of 300 patients from designated centres |
| Publications | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17079759 |
| Sources of funding | 1. Cancer Research UK
2. Pharmacia and Upjohn |
| Sponsor name | University of Birmingham (UK) |
| Sponsor details | RES, University of Birmingham, Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Sponsor telephone | +44 (0)121 414 7618 |
| Sponsor website | http://www.bham.ac.uk/ |
| Contact name | Dr Sarah Bowden |
| Contact details | CR UK Clinical Trials Unit, Institute for Cancer Studies, The University of Birmingham, Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Contact telephone | +44 (0)121 414 4371 |
| Contact fax | +44 (0)121 414 3700 |
| Contact email | BTT@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN42625759 |
| Date last extracted from ISRCTN register | 17/04/2008 |
