Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
06/11/2012
Prospective/Retrospective
Prospectively 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/6/89

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

Patients randomised to receive chemotherapy will receive CMF or FEC no sooner than 2 weeks and no later than 4 weeks following primary surgery.

Patients will receive either:
1. CMF Regimen: Chemotherapy, CMF (cyclophosphamide, methotrexate, 5-fluorouracil) repeated every 4 weeks for six cycles.
2. FEC Regimen: Chemotherapy, FEC (5-fluouracil, 4-epidoxorubicin, cyclophosphamide) repeated every 4 weeks for six cycles.

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

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged less than 65 years
2. Histologically proven invasive adenocarcinoma axillary nodes must be histologically negative
3. Tumour is T1c to T3
4. Tumour shows one of the following features of poor prognosis:
4.1. Oestrogen receptor less than or equal to 10 fmol/mg cytosol protein
4.2. Grade III
4.3. Vessel invasive
4.4. High labelling index of S phase
4.5. Aneuploidy
4.6. Tumour size at least 2 cm
5. Adequate renal, hepatic and haematological function
6. No evidence of metastatic disease
7. No evidence of inflammatory carcinoma
8. Patients with bilateral malignancy or with a mass in the opposite breast, unless there is biopsy proof that it is not a malignancy, are excluded
9. Patients with findings that relate them to a category of more advanced disease are not eligible
10. Patients with clinically positive nodes in the axilla opposite the affected breast, or with palpable supraclavicular or infraclavicular nodes are considered ineligible unless there is a biopsy evidence that these are not involved with the tumour
11. No previous or concomitant malignancy, except squamous or basal cell carcinoma which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively
12. No prior therapy for the present breast cancer including radiotherapy, chemotherapy, immunotherapy and/or hormonal therapy
13. No non-malignant systemic disease which would preclude their being subjected to any of the treatment options or prevent prolonged follow up
14. No active or previous cardiac disease that would preclude the use of 4-epidoxorubicin
12. No psychiatric or addictive disorders which should preclude obtaining informed consent

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

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Pharmacia Ltd & Upjohn (UK)

Sponsor details

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk

Sponsor type

Industry

Website

http://www.pharmacia.com

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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