Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/10/92
Study information
Scientific title
High Dose Therapy in Poor-Risk Primary 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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Breast cancer
Intervention
1. 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
28/09/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1999
Recruitment end date
28/09/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Amgen Limited (UK)
Sponsor details
240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Amgen (UK)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
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
Basic results (scientific)
Publication list