A trial to study the place of surgery in elderly women with breast cancer treated by tamoxifen

ISRCTN	ISRCTN72493595
DOI	https://doi.org/10.1186/ISRCTN72493595
Protocol serial number	CRCBCTG6
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Not provided at time of registration

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
Study type	Participant information sheet
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
Intervention	1. Group A: Optimal surgery plus tamoxifen, 20 mg twice daily 2. Group B: Tamoxifen, 20 mg twice daily All patients receive tamoxifen until there is evidence of progressive disease.
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	31/12/1997

Participant type(s)	Patient
Age group	Senior
Sex	Female
Key inclusion criteria	1. Aged >70 years 2. Histological, cytological or unequivocal mammographic confirmation of carcinoma of the breast 3. Operable breast cancer 4. No metastases 5. No previous malignancy, except skin cancer or adequately treated in situ carcinoma of the cervix 6. Fit and willing to receive either treatment
Key exclusion criteria	1. Patients with bilateral breast cancer are excluded 2. Patients with Paget's disease without a palpable lump, in situ carcinoma or an impalpable lesion shown on mammograph alone are excluded
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/1997

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	01/08/1997		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes