Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR9601

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Breast cancer

Intervention

1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight 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

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

30/04/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed breast cancer
2. Histologically confirmed axillary node metastases
3. Fit to receive chemotherapy on either arm of the trial
4. Adequate hepatic, renal and bone marrow function
5. No previous chemotherapy
6. No prior or concomitant malignancy, except basal cell carcinoma or in situ carcinoma of the cervix
7. No bilateral breast tumours or locally advanced or metastatic breast cancer, including supraclavicular fossa metastases

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

30/04/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Pharmacia Ltd & Upjohn (UK)

Sponsor details

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk

Sponsor type

Industry

Website

http://www.pharmacia.com

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn (UK)

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17079759

Publication citations

  1. Results

    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