Plain English Summary
http://www.cancerhelp.org.uk/trials/national-breast-cancer-study-of-epirubicin-as-adjuvant-therapy
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sarah Bowden
ORCID ID
Contact details
CR UK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 4371
BTT@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003577
Protocol/serial number
BR3014
Study information
Scientific title
Acronym
NEAT
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Epirubicin plus CMF versus classical CMF Adjuvant Therapy
Primary outcome measures
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 trial start date
30/04/1996
Overall trial end date
31/07/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Target: 2000 patients. Recruited: 2028
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/04/1996
Recruitment end date
31/07/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CR UK Clinical Trials Unit, Institute for Cancer Studies, The University of Birmingham, Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
RES
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Pharmacia and Upjohn
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Poole CJ, Earl HM, Hiller L, Dunn JA, Bathers S, Grieve RJ, Spooner DA, Agrawal RK, Fernando IN, Brunt AM, O'Reilly SM, Crawford SM, Rea DW, Simmonds P, Mansi JL, Stanley A, Harvey P, McAdam K, Foster L, Leonard RC, Twelves CJ, , Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer., N. Engl. J. Med., 2006, 355, 18, 1851-1862, doi: 10.1056/NEJMoa052084.