Plain English Summary
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17079759
Publication citations
-
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.