Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C136
Study information
Scientific title
A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
Acronym
Study hypothesis
Not provided at time of registration
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
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
Intervention type
Drug
Phase
Phase III
Drug names
Theratope
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Cancer organisations
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