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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN66842537 |
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Date of registration:
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12/09/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised phase II trial comparing vinorelbine and capecitabine with docetaxel and capecitabine chemotherapy for metastatic breast cancer
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Scientific title:
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Date of first enrolment:
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01/04/2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN66842537 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Chris
Gallagher |
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Address:
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Consultant
Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
EC1A 7BE
London
United Kingdom |
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Telephone:
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+44 (0)20 7601 8521 |
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Email:
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chris.gallagher@bartsandthelondon.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Metastatic breast cancer following initially histologically proven adenocarcinoma of the breast.
Exclusion criteria: Exclusions include previous treatment with vinorelbine, docetaxel or capecitabine and presence of other primary cancers.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast cancer
Cancer
Breast
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Intervention(s)
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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.
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Primary Outcome(s)
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Toxicity, response and survival.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0205108870
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Source(s) of Monetary Support
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Barts and The London NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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