Randomised phase II trial comparing vinorelbine and capecitabine with docetaxel and capecitabine chemotherapy for metastatic breast cancer

ISRCTN	ISRCTN66842537
DOI	https://doi.org/10.1186/ISRCTN66842537
Protocol serial number	N0205108870
Sponsor	Department of Health (UK)
Funder	Barts and The London NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Chris Gallagher
Scientific

Consultant
Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Phone	+44 (0)20 7601 8521
Email	chris.gallagher@bartsandthelondon.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Toxicity, response and survival.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Randomisation will be stratified by previous anthracycline exposure. 1. Vinorelbine 25mg/m^2 intravenous (IV) 30 min DI + 8q 21 days. Capecitabine 1 g/m^2 orally, twice daily for 14 in every 21 days. 2. Docetaxel 75 mg/m^2 IV 60 min every 21 days with dexamethasone 8 mg twice daily for three days starting 24 hours before each docetaxel treatment. Capecitabine 1 g/m^2 orally, twice daily for 14 in every 21 days. Added 17 July 2008: the trial closed in 2006 due to poor recruitment.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Vinorelbine and capecitabine
Primary outcome measure(s)	Toxicity, response and survival.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	25/11/2005
Reason abandoned (if study stopped)	Poor recruitment

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	100
Key inclusion criteria	Metastatic breast cancer following initially histologically proven adenocarcinoma of the breast.
Key exclusion criteria	Exclusions include previous treatment with vinorelbine, docetaxel or capecitabine and presence of other primary cancers.
Date of first enrolment	01/04/2002
Date of final enrolment	25/11/2005

Consultant

London
EC1A 7BE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan