A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
ISRCTN | ISRCTN91516565 |
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DOI | https://doi.org/10.1186/ISRCTN91516565 |
Secondary identifying numbers | C136 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 10/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
- - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Theratope |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2000 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
https://ror.org/054225q67 |
Funders
Funder type
Research organisation
Cancer organisations
No information available
Results and Publications
Intention to publish date | |
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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 |