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/2/84

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

Intervention

All patients receive either a total mastectomy or tumour excision followed by radiotherapy. Eligible patients are randomised to receive:

A. PRE-MENOPAUSAL PATIENTS
1. Regimen A: Chemotherapy, 5-fluorouracil, 4-epidoxorubicin and cyclophosphamide (FEC), repeated every 3 weeks for a total of eight cycles.
2. Regimen B: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF), repeated every 4 weeks for a total of six cycles.

B. POST-MENOPAUSAL PATIENTS
3. Regimen C: Chemotherapy with FEC repeated every 3 weeks for a total of eight cycles.
4. Regimen D: No chemotherapy.

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

01/01/1987

Overall trial end date

15/04/1992

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged <65 years
2. Tumour confined to the breast or breast and ipsilateral axilla and considered operable
3. At least one axillary lymph node must show evidence of tumour on histological examination
4. On clinical examination, the axillary nodes should be moveable in relation to the chest wall and neurovascular bundle, and there should be no oedema of the arm
5. Adequate renal, hepatic and haematological function
6. No previous oophorectomy for breast carcinoma
7. No evidence of metastatic disease
8. Patients with advanced disease or ulceration, erythema, infiltration of the skin and oedema are ineligible
9. No previous concomitant malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in-situ of the cervix
10. No non-malignant systemic disease which would preclude the use of any treatment within the trial

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

01/01/1987

Recruitment end date

15/04/1992

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

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