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Note: This record shows only 22 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:	13 January 2020
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:	01/07/1996
Target sample size:	20000
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12606000533594.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
Phase:	Phase 3

Countries of recruitment
Australia	New Zealand

Contacts

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:

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:

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: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Cancer - Breast

Early Breast Cancer;
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)[After 5 years additional treatment.]

Secondary Outcome(s)

N/A[N/A]

Secondary ID(s)

National Clinical Trials Registry: NCTR438

Institute of Clinical Research: CTA 21584/0002/001

European Clinical Trials Database (EUDRACT): 2004-000735-29

Source(s) of Monetary Support

Breast Cancer Trials

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Orange Base Hospital