High Dose Therapy in Poor-Risk Primary Breast Cancer

ISRCTN ISRCTN52623943
DOI https://doi.org/10.1186/ISRCTN52623943
Secondary identifying numbers ICCG/10/92
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
26/03/2020
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

Dr - -
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)Not specified
Study typeNot Specified
Scientific titleHigh Dose Therapy in Poor-Risk Primary 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. Regimen A: Chemotherapy, 5-fluorouracil, epirubicin and cyclophosphamide (FEC), one 3 week cycle, then FEC repeated every 4 weeks for five cycles.

2. Regimen B: Chemotherapy, FEC one 3 week cycle, then FEC repeated every 4 weeks for five cycles followed by high dose therapy with cyclophosphamide, thiotepa and carboplatin and peripheral blood stem cell support.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1999
Completion date28/09/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Complete prior resection of tumour and axillary node clearance
2. Histologically proven T1-T4 primary breast cancer with at least four involved nodes in the axilla
3. Adequate local therapy as defined in the protocol
4. Aged <60 years
5. No previous malignancy or evidence of metastatic disease
6. Fit to receive treatment
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1999
Date of final enrolment28/09/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Amgen Limited (UK)
Industry

240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom

Website http://www.amgen.com
ROR logo "ROR" https://ror.org/02gvvc992

Funders

Funder type

Industry

Amgen (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Location
United States of America

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

Editorial Notes

26/03/2020: No publications found. All search options exhausted.