Condition category
Cancer
Date applied
22/03/2001
Date assigned
22/03/2001
Last edited
01/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Martin J Lee

ORCID ID

Contact details

Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003678

Protocol/serial number

BR3009

Study information

Scientific title

Acronym

aTTom

Study hypothesis

To assess reliably, the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years, in women with early breast cancer

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

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Group A - No further treatment with tamoxifen
Group B - At least 5 years further treatment with tamoxifen

Intervention type

Drug

Phase

Not Specified

Drug names

Tamoxifen

Primary outcome measures

To detect or refute reliably any overall survival benefit from extending the duration of therapy with adjuvant tamoxifen

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1994

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any woman who has had complete excision of breast carcinoma
2. Any primary treatment
3. At least 2 years of prior adjuvant tamoxifen treatment (5 recommended)
4. Clinically relapse free
5. No definite indications or contraindications for further tamoxifen treatment: uncertainty as to whether further tamoxifen treatment will be of benefit
6. Where possible, ER status should be known prior to randomisation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

8000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1994

Recruitment end date

01/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Clinical Trials Unit
Birmingham
B15 2RR
United Kingdom

Sponsor information

Organisation

The University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Medical Research UK (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