Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
11/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002580

Protocol/serial number

BR9401

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Tamoxifen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1993

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed invasive carcinoma of the breast
2. Pre-menopausal
3. No medical contraindications to treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1993

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Scottish Cancer Therapy Network (UK)

Sponsor details

Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Scottish Cancer Therapy Network (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes