A multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer

ISRCTN ISRCTN91516565
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA multicentre phase III randomised controlled study of Theratope vaccine for metastatic breast cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Theratope
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Research organisation

Cancer organisations

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan