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A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
Source of recordUK Clinical Trials Gateway
ISRCTNISRCTN91516565
Date ISRCTN assigned19/08/2002
Local reference number(s)C136
Public titleA multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
Scientific title
AcronymNot Applicable
Disease/condition/study domainBreast
Study hypothesisNot provided at time of registration
Design/methodologyRandomised controlled trial
Research ethics reviewNot provided at time of registration
Countries of trialUnited Kingdom
Participants - inclusion criteria1. Must have received 4-8 cycles or 12-24 weeks duration of first line chemotherapy for metastatic disease
2. Has either no evidence of disease of non-progressive disease following first line chemotherapy or stable disease
Participants - exclusion criteriaNot provided at time of registration
Patient information material
Status of trialCompleted
Target number of participantsNot provided at time of registration
InterventionsTwo Arms:
1. Theratope s/c injections 100 mg with detox at weeks 0, 2, 5 and 9
2. Control injection Keyhole limpet heamocyanin 100 mg with detox at weeks 0, 2, 5 and 9
Primary outcome measure(s)Not provided at time of registration
Secondary outcome measure(s)Not provided at time of registration
Sources of fundingNot available
Sponsor nameUK Co-ordinating Committee for Cancer Research (UKCCCR)
Sponsor detailsMRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA
Sponsor telephone+44 (0) 20 7670 4723
Sponsor fax+44 (0) 20 7670 4818
Sponsor emailregister@ctu.mrc.ac.uk
Sponsor websitehttp://www.ctu.mrc.ac.uk/ukcccr/home.html
Contact nameDr - -
Contact detailsUKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA
Contact telephone+44 (0) 20 7670 4723
Contact fax+44 (0) 20 7670 4818
Contact emailregister@ctu.mrc.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN91516565
Date last extracted from ISRCTN register17/04/2008
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