ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000527561

Ethics application status

Approved

Date submitted

20/03/1998

Date registered

20/03/1998

Date last updated

5/12/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

ATAC - Arimidex, Tamoxifen, Alone or in Combination

Scientific title

A randomised, double-blind trial comparing Arimidex alone with Nolvadex alone with Arimidex and Nolvadex in combination, as adjuvant treatment in post-menopausal women with breast cancer.

Secondary ID [1]

National Clinical Trials Registry: NCTR219

Universal Trial Number (UTN)

Trial acronym

ATAC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients are randomised to receive one of three treatment regimens:
* Arimidex 1mg orally daily for 5 years + Nolvadex placebo orally daily for 5 years
* Arimidex placebo orally daily for 5 years + Nolvadex 20 mg orally daily for 5 years
* Arimidex 1mg orally daily for 5 years + Nolvadex 20mg orally daily for 5 years

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

to be confirmed

Control group

Active

Outcomes

Primary outcome [1]

To compare Tamoxifen and Arimidex and to compare Tamoxifen and the combination of Arimidex plus Tamoxifen in terms of time to recurrence of breast cancer.

Timepoint [1]

The trial statistician will monitor the number of recurrences. One interim analysis will be conducted when approximately half the expected number of events (352/2=176) has occurred in any one arm.

The major trial analysis will be performed when approximately 352 disease recurrence events have occurred in any one treatment arm. This analysis occurred in quarter 4 2004.

A Data Safety Monitoring Committee has been established and reviews the safety data periodically and also considers the results from the interim and main analysis.

Primary outcome [2]

To compare Tamoxifen and Arimidex and to compare Tamoxifen and the combination of Arimidex plus Tamoxifen in terms of Safety and side effects.

Timepoint [2]

Secondary outcome [1]

To compare Tamoxifen and Arimidex and to compare Tamoxifen and the combination of Arimidex plus Tamoxifen in terms of: Time to distant recurrence

Timepoint [1]

Secondary outcome [2]

To compare Tamoxifen and Arimidex and to compare Tamoxifen and the combination of Arimidex plus Tamoxifen in terms of: Survival

Timepoint [2]

The formal statistical analysis of time to death will be undertaken when approximately 352 deaths have occurred in any one treatment arm.

Secondary outcome [3]

To compare Tamoxifen and Arimidex and to compare Tamoxifen and the combination of Arimidex plus Tamoxifen in terms of: New breast primaries

Timepoint [3]

to be confirmed

Eligibility

Key inclusion criteria

Histologically proven operable invasive breast cancer. Patients who completed all primary surgery and chemotherapy and are candidates to receive hormonal adjuvant therapy. Post-menopausal women according to one or more of the following: a) aged 60 or > b) aged 45-59 and satisfying one or more of the following: i) amenorrhea for at least 12 months and intact uterus ii) amenorrhea < 12 months and FSH within post-menopausal range; including: Patients who have had hysterectomy. Patients who received HRT. Patients rendered amenorrhoeic by adjuvant chemotherapy iii) bilateral oophorectomy.

Minimum age

18 Years

Maximum age

Not stated

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Clinical evidence of metastatic disease. Patients unlikey to comply with trial requirements. Patients whose chemotherapy started > 8 weeks after completion of primary surgery or whose chemotherapy completed > 8 weeks before starting randomised treatment. Patients who have not received chemotherapy and whose primary surgery completed > 8 weeks before starting randomised treatment. Patients who received previous hormonal therapy as adjuvant treatment for breast cancer, unless: a) this was tamoxifen started prior to first surgical procedure and received < 29 days orb) this was hormonal therapy received pre-surgery in context of a formal trial, approved by Steering Committee. Patients who received tamoxifen as part of any breast cancer prevention trials, e.g. IBIS. Patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop. Previous history of invasive breast cancer or other invasive malignancy within last 10 years, other than squamous or basal cell carcinoma of skin or carcinoma in situ of cervix, adequately cone biopsied. Any severe concomitant disease placing patient at unusual risk or confound results of trial. Treatment with nonapproved or experimental drug 3 mths prior to randomisation. Patients at risk of transmitting any infection through blood or body fluids.

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)

The ANZ BCTG Operations Office provides a central randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants will be allocated a treatment code and study drug will be supplied in accordance with the treatment code.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated stratified blocks

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects and investigators (clinicians assessing patients) are blinded to treatment.

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/1998

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

6000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Australia and New Zealand Breast Cancer Trials Group

Address [1]

PO Box 155
Hunter Region Mail Centre NSW 2310

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

AstraZeneca

Address [2]

Postal Address
AstraZeneca P.O. Box 131
North Ryde NSW 1670

Country [2]

Australia

Primary sponsor type

Commercial sector/Industry

Name

AstraZeneca (formerly known as Zeneca, formerly known as ICI)

Address

Postal Address
AstraZeneca P.O. Box 131
North Ryde NSW 1670

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Australia and New Zealand Breast Cancer Trials Group

Address [1]

PO Box 155
Hunter Region Mail Centre NSW 2310

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Box Hill Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Liverpool Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Maroondah Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Monash Medical Centre

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

Newcastle Mater Misericordiae Hospital

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

Ethics committee name [6]

Peter MacCallum Cancer Centre

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

Prince of Wales Hospital

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

Ethics approval number [7]

Ethics committee name [8]

Royal Adelaide Hospital

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

Royal Prince Alfred Hospital

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

St Vincent's Hospital, Melbourne

Ethics committee address [10]

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

Ethics committee name [11]

Waikato Hospital

Ethics committee address [11]

Ethics committee country [11]

New Zealand

Date submitted for ethics approval [11]

Approval date [11]

Ethics approval number [11]

Summary

Brief summary

The ATAC trial is testing an alternative, new agent, to tamoxifen for women with early breast cancer.  The new agent, Arimidex, is an aromatase inhibitor which acts to reduce the level of circulating oestrogen in post menopausal women. This drug seems to be well tolerated and also effective against breast cancer. 

The ATAC trial is a double blind study comparing 5 years of tamoxifen, with 5 years of Arimidex, and with 5 years of tamoxifen plus Arimidex. In addition, there are three very important sub studies which investigate the effects of the treatments on bone, the endometrium and quality of life (QOL). Australia had a high rate of recruitment to the QOL sub study and is also one of the few countries contributing to the endometrial sub study. 

The ATAC trial is one of the largest (over 9000 women internationally) and most rapidly completed breast cancer studies in the world. Active accrual to the main study and sub-studies was completed internationally in May 2000, and patient follow-up continues.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Australia and New Zealand Breast Cancer Trials Group

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 3068

Fax

+61 2 49850141

[email protected]

Contact person for scientific queries

Name

Prof. John F. Forbes

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 3068

Fax

+61 2 4985 0141

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically