A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
| ISRCTN | ISRCTN91516565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91516565 |
| Protocol serial number | C136 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Cancer organisations |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Theratope |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
