Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
13/06/2014
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

Protocol/serial number

CRCBCTG6

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

31/12/1997

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

01/01/1995

Recruitment end date

31/12/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

1997 results in: http://www.ncbi.nlm.nih.gov/pubmed/9315064

Publication citations

  1. Results

    al-Hilaly M, Willsher PC, Robertson JF, Blamey RW, Audit of a conservative management policy of the axilla in elderly patients with operable breast cancer., Eur J Surg Oncol, 1997, 23, 4, 339-340.

Additional files

Editorial Notes