Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000533594
Ethics application status
Approved
Date submitted
17/12/2003
Date registered
17/12/2003
Date last updated
12/02/2018
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 39 0
National Clinical Trials Registry: NCTR438
Secondary ID [2] 40 0
European Clinical Trials Database (EUDRACT): 2004-000735-29
Secondary ID [3] 41 0
Institute of Clinical Research: CTA 21584/0002/001
Universal Trial Number (UTN)
Trial acronym
ANZ 9602 (ATLAS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 37 0
Condition category
Condition code
Cancer 44 44 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1248 0
Treatment: Drugs
Comparator / control treatment
20mg Tamoxifen for a further 5 years
Control group
Active

Outcomes
Primary outcome [1] 77 0
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)
Timepoint [1] 77 0
After 5 years additional treatment.
Secondary outcome [1] 151 0
N/A
Timepoint [1] 151 0
N/A

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated stratified blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/1995
Actual
1/07/1996
Date of last participant enrolment
Anticipated
Actual
1/03/2005
Date of last data collection
Anticipated
31/03/2017
Actual
31/03/2017
Sample size
Target
20000
Accrual to date
Final
15252
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 9232 0
New Zealand
State/province [1] 9232 0
N/A

Funding & Sponsors
Funding source category [1] 62 0
Self funded/Unfunded
Name [1] 62 0
Breast Cancer Trials
Country [1] 62 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 48 0
None
Name [1] 48 0
N/A
Address [1] 48 0
Country [1] 48 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 467 0
Auckland Hospital
Ethics committee address [1] 467 0
Ethics committee country [1] 467 0
New Zealand
Date submitted for ethics approval [1] 467 0
Approval date [1] 467 0
Ethics approval number [1] 467 0
Ethics committee name [2] 468 0
Austin Health
Ethics committee address [2] 468 0
Ethics committee country [2] 468 0
Australia
Date submitted for ethics approval [2] 468 0
Approval date [2] 468 0
Ethics approval number [2] 468 0
Ethics committee name [3] 469 0
Ballarat Health Services
Ethics committee address [3] 469 0
Ethics committee country [3] 469 0
Australia
Date submitted for ethics approval [3] 469 0
Approval date [3] 469 0
Ethics approval number [3] 469 0
Ethics committee name [4] 470 0
Ballarat Oncology and Haematology Services
Ethics committee address [4] 470 0
Ethics committee country [4] 470 0
Australia
Date submitted for ethics approval [4] 470 0
Approval date [4] 470 0
Ethics approval number [4] 470 0
Ethics committee name [5] 471 0
Bendigo Hospital
Ethics committee address [5] 471 0
Ethics committee country [5] 471 0
New Zealand
Date submitted for ethics approval [5] 471 0
Approval date [5] 471 0
Ethics approval number [5] 471 0
Ethics committee name [6] 472 0
Border Medical Oncology
Ethics committee address [6] 472 0
Ethics committee country [6] 472 0
Australia
Date submitted for ethics approval [6] 472 0
Approval date [6] 472 0
Ethics approval number [6] 472 0
Ethics committee name [7] 473 0
Box Hill Hospital
Ethics committee address [7] 473 0
Ethics committee country [7] 473 0
Australia
Date submitted for ethics approval [7] 473 0
Approval date [7] 473 0
Ethics approval number [7] 473 0
Ethics committee name [8] 474 0
Canberra Hospital
Ethics committee address [8] 474 0
Ethics committee country [8] 474 0
Australia
Date submitted for ethics approval [8] 474 0
Approval date [8] 474 0
Ethics approval number [8] 474 0
Ethics committee name [9] 475 0
Christchurch Hospital
Ethics committee address [9] 475 0
Ethics committee country [9] 475 0
New Zealand
Date submitted for ethics approval [9] 475 0
Approval date [9] 475 0
Ethics approval number [9] 475 0
Ethics committee name [10] 476 0
Dubbo Base Hospital
Ethics committee address [10] 476 0
Ethics committee country [10] 476 0
Australia
Date submitted for ethics approval [10] 476 0
Approval date [10] 476 0
Ethics approval number [10] 476 0
Ethics committee name [11] 477 0
Geelong Hospital
Ethics committee address [11] 477 0
Ethics committee country [11] 477 0
Australia
Date submitted for ethics approval [11] 477 0
Approval date [11] 477 0
Ethics approval number [11] 477 0
Ethics committee name [12] 478 0
Women's Health Program
Ethics committee address [12] 478 0
Ethics committee country [12] 478 0
Australia
Date submitted for ethics approval [12] 478 0
Approval date [12] 478 0
Ethics approval number [12] 478 0
Ethics committee name [13] 479 0
Launceston General Hospital
Ethics committee address [13] 479 0
Ethics committee country [13] 479 0
Australia
Date submitted for ethics approval [13] 479 0
Approval date [13] 479 0
Ethics approval number [13] 479 0
Ethics committee name [14] 480 0
Lismore Base Hospital
Ethics committee address [14] 480 0
Ethics committee country [14] 480 0
Australia
Date submitted for ethics approval [14] 480 0
Approval date [14] 480 0
Ethics approval number [14] 480 0
Ethics committee name [15] 481 0
Liverpool Hospital
Ethics committee address [15] 481 0
Ethics committee country [15] 481 0
Australia
Date submitted for ethics approval [15] 481 0
Approval date [15] 481 0
Ethics approval number [15] 481 0
Ethics committee name [16] 482 0
Maroondah Hospital
Ethics committee address [16] 482 0
Ethics committee country [16] 482 0
Australia
Date submitted for ethics approval [16] 482 0
Approval date [16] 482 0
Ethics approval number [16] 482 0
Ethics committee name [17] 483 0
Mater Hospital
Ethics committee address [17] 483 0
Ethics committee country [17] 483 0
Australia
Date submitted for ethics approval [17] 483 0
Approval date [17] 483 0
Ethics approval number [17] 483 0
Ethics committee name [18] 484 0
Mount Hospital
Ethics committee address [18] 484 0
Ethics committee country [18] 484 0
Australia
Date submitted for ethics approval [18] 484 0
Approval date [18] 484 0
Ethics approval number [18] 484 0
Ethics committee name [19] 485 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [19] 485 0
Ethics committee country [19] 485 0
Australia
Date submitted for ethics approval [19] 485 0
Approval date [19] 485 0
Ethics approval number [19] 485 0
Ethics committee name [20] 486 0
Orange Base Hospital
Ethics committee address [20] 486 0
Ethics committee country [20] 486 0
Australia
Date submitted for ethics approval [20] 486 0
Approval date [20] 486 0
01/07/1996
Ethics approval number [20] 486 0
Ethics committee name [21] 487 0
Port Macquarie Base Hospital
Ethics committee address [21] 487 0
Ethics committee country [21] 487 0
Australia
Date submitted for ethics approval [21] 487 0
Approval date [21] 487 0
Ethics approval number [21] 487 0
Ethics committee name [22] 488 0
Prince of Wales Hospital
Ethics committee address [22] 488 0
Ethics committee country [22] 488 0
Australia
Date submitted for ethics approval [22] 488 0
Approval date [22] 488 0
Ethics approval number [22] 488 0
Ethics committee name [23] 489 0
Queen Elizabeth Hospital
Ethics committee address [23] 489 0
Ethics committee country [23] 489 0
Australia
Date submitted for ethics approval [23] 489 0
Approval date [23] 489 0
Ethics approval number [23] 489 0
Ethics committee name [24] 490 0
Royal Hobart Hospital
Ethics committee address [24] 490 0
Ethics committee country [24] 490 0
Australia
Date submitted for ethics approval [24] 490 0
Approval date [24] 490 0
Ethics approval number [24] 490 0
Ethics committee name [25] 491 0
Royal North Shore Hospital
Ethics committee address [25] 491 0
Ethics committee country [25] 491 0
Australia
Date submitted for ethics approval [25] 491 0
Approval date [25] 491 0
Ethics approval number [25] 491 0
Ethics committee name [26] 492 0
Royal Prince Alfred Hospital
Ethics committee address [26] 492 0
Ethics committee country [26] 492 0
Australia
Date submitted for ethics approval [26] 492 0
Approval date [26] 492 0
Ethics approval number [26] 492 0
Ethics committee name [27] 493 0
Sir Charles Gairdner Hospital
Ethics committee address [27] 493 0
Ethics committee country [27] 493 0
Australia
Date submitted for ethics approval [27] 493 0
Approval date [27] 493 0
Ethics approval number [27] 493 0
Ethics committee name [28] 494 0
Sydney Haematology and Oncology
Ethics committee address [28] 494 0
Ethics committee country [28] 494 0
Australia
Date submitted for ethics approval [28] 494 0
Approval date [28] 494 0
Ethics approval number [28] 494 0
Ethics committee name [29] 495 0
Tamworth Base Hospital
Ethics committee address [29] 495 0
Ethics committee country [29] 495 0
Australia
Date submitted for ethics approval [29] 495 0
Approval date [29] 495 0
Ethics approval number [29] 495 0
Ethics committee name [30] 496 0
Toowoomba Hospital
Ethics committee address [30] 496 0
Ethics committee country [30] 496 0
Australia
Date submitted for ethics approval [30] 496 0
Approval date [30] 496 0
Ethics approval number [30] 496 0
Ethics committee name [31] 497 0
Townsville General Hospital
Ethics committee address [31] 497 0
Ethics committee country [31] 497 0
Australia
Date submitted for ethics approval [31] 497 0
Approval date [31] 497 0
Ethics approval number [31] 497 0
Ethics committee name [32] 498 0
Tweed Hospital
Ethics committee address [32] 498 0
Ethics committee country [32] 498 0
Australia
Date submitted for ethics approval [32] 498 0
Approval date [32] 498 0
Ethics approval number [32] 498 0
Ethics committee name [33] 499 0
Westmead Hospital
Ethics committee address [33] 499 0
Ethics committee country [33] 499 0
Australia
Date submitted for ethics approval [33] 499 0
Approval date [33] 499 0
Ethics approval number [33] 499 0

Summary
Brief summary
Trials of adjuvant tamoxifen in women with early breast cancer have demonstrated a highly significant improvement in 10-year survival. However it is not yet known how long women with early breast cancer should continue to take adjuvant tamoxifen. The ATLAS trial will determine if it is better to stop taking tamoxifen after 5 years, or continue taking it for another 5 years (10 years in total).
Trial website
www.breastcancertrials.org.au
Trial related presentations / publications
Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, Abraham M, Alencar VHM, Badran A, Bonfill X, Bradbury J, Clarke M, Collins R, Davis SR, Delmestri A, Forbes JF, Haddad P, Hou M-F, Inbar M, Khaled H, Keilanowska J, Kwan W-H, Mathew BS, Müller B, Nicolucci A, Peralta O, Pernas F, Petruzelka L, Peinkowski T, Ragan B, Rubach MT, Tort S, Urrútia G, Valentini M, Wang Y, Peto R, for the ATLAS Collaborative Group Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial The Lancet 2013; 381:805-816.
Public notes
Breast Cancer Trials formerly known as the Australia & New Zealand Breast Cancer Trials Group.

Contacts
Principal investigator
Name 35469 0
A/Prof Shane White
Address 35469 0
Austin Health
Medical Oncology Unit
Level 6 Harold Stokes Building
Austin Health Studley Road
HEIDELBERG VIC 3084
Country 35469 0
Australia
Phone 35469 0
+61 (03) 9496-3549
Fax 35469 0
Email 35469 0
shane.white@nh.org.au
Contact person for public queries
Name 10437 0
Ms Corinna Beckmore
Address 10437 0
BCT
PO Box 283
The Junction NSW 2291
Country 10437 0
Australia
Phone 10437 0
+61 2 4925 5235
Fax 10437 0
+61 2 4925 3068
Email 10437 0
corinna.beckmore@bctrials.org.au
Contact person for scientific queries
Name 1365 0
A/Prof Shane White
Address 1365 0
Austin Health
Medical Oncology Unit
Level 6 Harold Stokes Building
Austin Health Studley Road
HEIDELBERG VIC 3084
Country 1365 0
Australia
Phone 1365 0
+61 (03) 9496-3549
Fax 1365 0
Email 1365 0
shane.white@nh.org.au

No information has been provided regarding IPD availability


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