Contact information
Type
Scientific
Primary contact
Dr Chris Gallagher
ORCID ID
Contact details
Consultant
Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 8521
chris.gallagher@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205108870
Study information
Scientific title
Acronym
Study hypothesis
Toxicity, response and survival.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Vinorelbine and capecitabine
Primary outcome measures
Toxicity, response and survival.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2002
Overall trial end date
25/11/2005
Reason abandoned
Poor recruitment
Eligibility
Participant inclusion criteria
Metastatic breast cancer following initially histologically proven adenocarcinoma of the breast.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
100
Participant exclusion criteria
Exclusions include previous treatment with vinorelbine, docetaxel or capecitabine and presence of other primary cancers.
Recruitment start date
01/04/2002
Recruitment end date
25/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (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