Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes