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

ISRCTN	ISRCTN42625759
DOI	https://doi.org/10.1186/ISRCTN42625759
ClinicalTrials.gov (NCT)	NCT00003577
Protocol serial number	BR3014
Sponsor	University of Birmingham (UK)
Funders	Cancer Research UK, Pharmacia and Upjohn

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Epirubicin plus CMF versus classical CMF Adjuvant Therapy
Primary outcome measure(s)	1. 5 year disease-free survival 2. 5 year overall survival
Key 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
Completion date	31/07/2001

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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

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