A randomised trial of epirubicin and cyclophosphamide versus epirubicin and paclitaxel in the treatment of women with metastatic breast cancer

ISRCTN	ISRCTN75147488
DOI	https://doi.org/10.1186/ISRCTN75147488
ClinicalTrials.gov number	NCT00002953
Secondary identifying numbers	AB01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Barbara Uscinska
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To compare epirubicin and paclitaxel versus epirubicin and cyclophosphamide in metastatic breast cancer
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer
Intervention	Epirubicin and paclitaxel/epirubicin and cyclophosphamide
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	epirubicin and cyclophosphamide versus epirubicin and paclitaxel
Primary outcome measure	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 study start date	01/12/1996
Completion date	05/11/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	700
Key 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
Key exclusion criteria	History of cardiac disease
Date of first enrolment	01/12/1996
Date of final enrolment	05/11/1999

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/11/2005		Yes	No