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 |
| Secondary identifying numbers | N0205108870 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 29/10/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
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
Contact information
Dr Chris Gallagher
Scientific
Scientific
Consultant
Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
| Phone | +44 (0)20 7601 8521 |
|---|---|
| chris.gallagher@bartsandthelondon.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Vinorelbine and capecitabine |
| Primary outcome measure | Toxicity, response and survival. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2002 |
| Completion date | 25/11/2005 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
No information available
Results and Publications
| 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 |
