A Prospective Randomised Comparison of CMF versus Sequential Epirubicin Followed by CMF as Adjuvant Chemotherapy for Women with Early Breast Cancer

ISRCTN	ISRCTN35478997
DOI	https://doi.org/10.1186/ISRCTN35478997
Secondary identifying numbers	BR9601

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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)	Not specified
Study type	Not Specified
Scientific title
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	1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles 2. Group B: Chemotherapy, epirubicin repeated every 3 weeks for four cycles followed by CMF repeated every 3 weeks for four cycles
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	30/04/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically confirmed breast cancer 2. Histologically confirmed axillary node metastases 3. Fit to receive chemotherapy on either arm of the trial 4. Adequate hepatic, renal and bone marrow function 5. No previous chemotherapy 6. No prior or concomitant malignancy, except basal cell carcinoma or in situ carcinoma of the cervix 7. No bilateral breast tumours or locally advanced or metastatic breast cancer, including supraclavicular fossa metastases
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	30/04/2001

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Pharmacia Ltd & Upjohn (UK)
Industry

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom

Industry

Pharmacia and Upjohn (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/11/2006		Yes	No