Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	15/04/1992

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1987
Date of final enrolment	15/04/1992

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/1996		Yes	No
Other publications	design and rationale	01/08/1993		Yes	No

11/01/2019: Publication references added.