Scottish Pre-Menopausal Chemo-Endocrine Trial

ISRCTN	ISRCTN95231655
DOI	https://doi.org/10.1186/ISRCTN95231655
ClinicalTrials.gov (NCT)	NCT00002580
Protocol serial number	BR9401
Sponsor	Scottish Cancer Therapy Network (UK)
Funder	Scottish Cancer Therapy Network (UK)

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	Following surgery patients are randomised to one of four treatment arms: 1. Group A: Tamoxifen 20 mg daily for 5 years 2. Group B: Tamoxifen 20 mg daily for 5 years plus six cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy 3. Group C: Tamoxifen 20 mg daily for 5 years plus ovarian suppression 4. Group D: Tamoxifen 20 mg daily for 5 years, six cycles of CMF chemotherapy and ovarian suppression
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tamoxifen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1000
Key inclusion criteria	1. Histologically confirmed invasive carcinoma of the breast 2. Pre-menopausal 3. No medical contraindications to treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1993
Date of final enrolment	31/12/2003

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	01/01/1999	14/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/04/2019: Internal review.
14/02/2019: Publication reference added.