Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002953
Protocol/serial number
AB01
Study information
Scientific title
Acronym
Study hypothesis
To compare epirubicin and paclitaxel versus epirubicin and cyclophosphamide in metastatic breast cancer
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
Cancer
Intervention
Epirubicin and paclitaxel/epirubicin and cyclophosphamide
Intervention type
Drug
Phase
Not Specified
Drug names
epirubicin and cyclophosphamide versus epirubicin and paclitaxel
Primary outcome measures
Progression free survival.
Secondary outcome measures
Overall survival, response, toxicity, quality of life (Fact-B Quality of Life, Questionnaire); and health economics (Cost and Resource Use Questionnaire).
Overall trial start date
01/12/1996
Overall trial end date
05/11/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Metastatic breast cancer previously untreated except in adjuvant setting
2. Exposure to anthracyclines limited
3. Treatment free interval more than 6 months
4. Normal ejection fraction
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
700
Participant exclusion criteria
History of cardiac disease
Recruitment start date
01/12/1996
Recruitment end date
05/11/1999
Locations
Countries of recruitment
South Africa, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293863
Publication citations
-
Results
Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M, Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01., J. Clin. Oncol., 2005, 23, 33, 8322-8330, doi: 10.1200/JCO.2005.01.1817.