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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 19 February 2018
Main ID:  ACTRN12606000533594
Date of registration: 17/12/2003
Prospective Registration: No
Primary sponsor: Breast Cancer Trials
Public title: Adjuvant tamoxifen - longer against shorter
Scientific title: Adjuvant tamoxifen longer against shorter (ATLAS) clinical trial in early breast cancer. Reliable assessment of the efficacy and safety of prolonging the use of adjuvant tamoxifen: a large, simple, randomised study.
Date of first enrolment: 1/07/1996
Target sample size: 20000
Recruitment status: Completed
URL:  http://www.anzctr.org.au/ACTRN12606000533594.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Phase:  Phase 3
Countries of recruitment
Australia New Zealand
Contacts
Name:     A/Prof Shane White
Address:  Austin Health Medical Oncology Unit Level 6 Harold Stokes Building Austin Health Studley Road HEIDELBERG VIC 3084, Australia
Telephone: +61 (03) 9496-3549
Email: shane.white@nh.org.au
Affiliation: 
Name:     Ms Corinna Beckmore
Address:  BCT PO Box 283 The Junction NSW 2291, Australia
Telephone: +61 2 4925 5235
Email: corinna.beckmore@bctrials.org.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Women who have received any type of curative surgery for early breast cancer are eligible (irrespective of the original histological type of the disease, nodal status, or whether the tumour was estrogen receptor positive or negative) so long as the woman appears currently to be free of breast cancer and is receiving tamoxifen and where both the woman and her doctor are uncertain whether to continue with tamoxifen.
Exclusion criteria: No exclusion criteria

Age minimum: 18 Years
Age maximum: 0 No limit
Gender: Females
Health Condition(s) or Problem(s) studied
Early Breast Cancer
Intervention(s)
Patients enter the trial after completing approximately 5 years of tamoxifen for early breast cancer and are randomised to either continue tamoxifen for a further 5 years or stop tamoxifen. The dosage of tamoxifen is recommended at 20mg.day orally unless the patient's clinician prefers a different dosage. Patients will continue to be followed for at least 5 years after completing treatment.
Primary Outcome(s)
The aim of ATLAS is to compare different durations of adjuvant tamoxifen therapy for early breast cancer to determine the optimum duration based on the evaluation of:
* All cause mortality
* Cause specific mortality (including breast cancer, myocardial infarct, and other cancers)
* Non fatal events (including new, contralateral primary breast cancer, other cancers, myocardial infarct and other vascular events requiring hospitalisation)
Secondary Outcome(s)
N/A
Secondary ID(s)
European Clinical Trials Database (EUDRACT): 2004-000735-29
Institute of Clinical Research: CTA 21584/0002/001
National Clinical Trials Registry: NCTR438
Source(s) of Monetary Support
Breast Cancer Trials
Secondary Sponsor(s)
N/A
Results
Results available:
Date Posted:
URL:
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