Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
09/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICCG/10/92

Study information

Scientific title

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 measures

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

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

http://www.amgen.com

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes