Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
02/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.bham.ac.uk/

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17079759

Publication citations

  1. 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.

Additional files

Editorial Notes