|
ISRCTN
|
ISRCTN91516565
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
C136
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Breast
|
|
Participants - inclusion criteria
|
1. 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 criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2000
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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 funding
|
Cancer organisations
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
UK Co-ordinating Committee for Cancer Research (UKCCCR)
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
14/05/2008
|
|
Date ISRCTN assigned
|
19/08/2002
|
