Epirubicin plus tamoxifen versus tamoxifen alone in post-menopausal 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
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. Regimen A: tamoxifen 20 mg daily for 4 years 2. Regimen B: tamoxifen 20 mg daily for 4 years plus chemotherapy, single agent epirubicin repeated every 4 weeks for six cycles
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	28/02/1998

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	604
Key inclusion criteria	1. Post-menopausal as determined by: 1.1. Last menstrual cycle 12 months before surgery 1.2. Patients any age with previous bilateral oophorectomy 1.3. Patients aged greater than 50 years who have had hysterectomy without oopherectomy as long as the reason for surgery was not a malignancy 2. Aged less than 75 years 3. Histologically proven non metastatic T1-T3 with at least one involved ipsilateral axillary node 4. Adequate renal and haematological function 5. No prior history of malignant breast tumours 6. No bilateral malignancy or inflammatory breast cancer 7. No previous or concomitant malignancy, except squamous or basal cell carcinoma of the skin which has been effectively treated or carcinoma of the cervix in situ which has been treated operatively only 8. No non malignant systemic disease 9. No definite indication for chemotherapy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1996
Date of final enrolment	28/02/1998

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	01/07/1999		Yes	No