National breast cancer study of Epirubicin plus CMF versus classical CMF Adjuvant Therapy

ISRCTN	ISRCTN42625759
DOI	https://doi.org/10.1186/ISRCTN42625759
ClinicalTrials.gov number	NCT00003577
Secondary identifying numbers	BR3014

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Sarah Bowden
Scientific

CR UK Clinical Trials Unit, Institute for Cancer Studies, The University of Birmingham, Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 4371
Email	BTT@bham.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	National breast cancer study of Epirubicin plus CMF versus classical CMF Adjuvant Therapy
Study acronym	NEAT
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Epirubicin plus CMF versus classical CMF Adjuvant Therapy
Primary outcome measure	1. 5 year disease-free survival 2. 5 year overall survival
Secondary outcome measures	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
Overall study start date	30/04/1996
Completion date	31/07/2001

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Target: 2000 patients. Recruited: 2028
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/04/1996
Date of final enrolment	31/07/2001

CR UK Clinical Trials Unit, Institute for Cancer Studies, The University of Birmingham, Edgbaston

Birmingham
B15 2TT
United Kingdom

University of Birmingham (UK)
University/education

RES, University of Birmingham, Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Industry

Cancer Research UK
Private sector organisation / Other non-profit organizations

Pharmacia and Upjohn

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	02/11/2006		Yes	No
Results article	results	21/10/2008	25/01/2019	Yes	No

25/01/2019: Publication reference added
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)