Clinical trial of six versus three courses of cyclophosphamide, methotrexate and 5-fluorouracil adjuvant chemotherapy in the treatment of pre-menopausal women with carcinoma of the breast

ISRCTN	ISRCTN43589852
DOI	https://doi.org/10.1186/ISRCTN43589852
Secondary identifying numbers	BR305

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Clinical trial of six versus three courses of cyclophosphamide, methotrexate and 5-fluorouracil adjuvant chemotherapy in the treatment of pre-menopausal women with carcinoma of the breast
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 cancer
Intervention	All patients receive surgery followed by: 1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 4 weeks for three cycles. 2. Group B: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 4 weeks for six cycles.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cyclophosphamide, methotrexate and 5-fluorouracil
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1994
Completion date	19/09/1996

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically proven invasive carcinoma of the breast 2. Aged <50 years 3. Axillary node positive with less than ten positive nodes, or node negative and deemed to be high risk: Grade 3; Grade 2 and tumour >2 cm; Grade 1 and tumour >5 cm 4. No evidence of distant metastases 5. No other malignancy, other than basal cell carcinoma or in situ cervical cancer or any malignancy with a similar prognosis 6. No previous chemotherapy 7. No contraindications to treatment protocols
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1994
Date of final enrolment	19/09/1996

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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