Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/2/84
Study information
Scientific title
Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive 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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 1993 design and rationale in https://www.ncbi.nlm.nih.gov/pubmed?term=7693422
2. 1996 results in https://www.ncbi.nlm.nih.gov/pubmed?term=8558217