Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000389606
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
IBCSG 30-04 / NCIC CTG MA.27
Scientific title
A randomised phase III trial of exemestane versus anastrozole in postmenopausal women with receptor positive primary breast cancer
Secondary ID [1] 287854 0
NCT00066573
Universal Trial Number (UTN)
Trial acronym
IBCSG 30-04 / NCIC CTG MA.27
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Receptor positive primary breast cancer 493 0
Condition category
Condition code
Cancer 573 573 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IBCSG 30-04 / NCIC CTG MA.27 is co-ordinated by the National Cancer Institute of Canada, Clinical Trials Group (NCIC CTG). The International Breast Cancer Study Group (IBCSG) is participating in the NCIC CTG MA.27 trial, and the ANZ Breast Cancer Trials Group (ANZ BCTG) contribution is part of the IBCSG collaboration. The trial is conducted in Australia and New Zealand by the ANZ Breast Cancer Trials Group.

This study will investigate which of two drugs (exemestane and anastrozole), if either, is better at preventing a recurrence of breast cancer in postmenopausal women with receptor positive, adequately excised, primary breast cancer.

IBCSG 30-04 / NCIC CTG MA.27 is an international, multicentre, randomised phase III clinical trial of 5800 postmenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer.

Women will be randomised in a 2-arm design to receive one of the following:

a. Exemestane 25mg
b. Anastrozole 1mg

All treatment will be on a daily basis for 5 years until recurrence or second malignancy is documented.
Intervention code [1] 431 0
Treatment: Drugs
Comparator / control treatment
Exemestane 25mg
Anastrozole 1mg
Control group
Active

Outcomes
Primary outcome [1] 658 0
To compare event free survival between women treated with exemestane or anastrozole as adjuvant therapy. The total duration of the study will be about 5 years.
Timepoint [1] 658 0
It will be measured when 847 events have been observed. It is estmated that 3.2 years of accrual and another 2 years of follow up will be required.
Secondary outcome [1] 1358 0
To compare overall survival and time to distant recurrence of women treated with exemestane with that of those receiving anastrozole as adjuvant therapy.
Timepoint [1] 1358 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [2] 1359 0
To compare incidence of new primary contralateral breast cancer in the different treatment groups.
Timepoint [2] 1359 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [3] 1360 0
To compare incidence of all clinical fractures and specifically hip and vertebral fractures in the different treatment groups.
Timepoint [3] 1360 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [4] 1361 0
To compare cardiovascular morbidity and mortality between exemestane and anastrozole.
Timepoint [4] 1361 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [5] 1362 0
To examine whether breast density changes with aromatase inhibitor therapy and also whether these therapy-induced changes are associated with plasma hormones and growth factors.
Timepoint [5] 1362 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [6] 1363 0
Drug levels of exemestane or anastrozole, genetic variation and breast cancer recurrence or contralateral events.
Timepoint [6] 1363 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.
Secondary outcome [7] 1364 0
To compare toxicities in the two different treatment groups.
Timepoint [7] 1364 0
Two interim analyses are planned for this study when 282 and 564 events are observed. It is projected that the analyses would be performed 2.7 and 3.9 years after the first patient is entered. Assuming a hazard ratio of 0.80 between exemestane and anastrozole is being detected, with a two-sided 5% level and 90% power, a total of 5800 patients accrued over 3.2 years will be needed and another 2 years of follow-up before 847 events are observed at the final analysis. The total duration of the study would be about 5 years.

Eligibility
Key inclusion criteria
Postmenopausal women with completely resected, histologically proven, hormone receptor-positive primary breast cancer who have a minimum life expectancy of 5 years and are accessible for follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Premenopausal women; patients with only receptor negative primary tumours; patients with locally recurrent or metastatic breast cancer; patients with history of other (non-breast) malignancies; patients receiving concurrent hormonal therapy with estrogens, progesterones, androgens, or SERMs; patients having received prior treatment with a recognised aromatase inhibitor; any prior treatment with tamoxifen or SERMS other than raloxifene; any prior treatment with hormones or steroids if not discontinued at least 3 weeks prior to randomization; patients with a prior diagnosis of an in-situ carcinoma in the contralateral breast treated with partial mastectomy and/or hormonal therapy.

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 Statistical Centre at the NHMRC Clinical Trials Centre, University of Sydney will provide 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 via a web-based randomization system 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)
Randomisation will be performed via a web-based computerised system, stratification by lymph node status and prior adjuvant chemotherapy (yes/no).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2005
Actual
10/11/2005
Date of last participant enrolment
Anticipated
Actual
1/12/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
5800
Accrual to date
Final
7576
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 623 0
Self funded/Unfunded
Name [1] 623 0
ANZ Breast Cancer Trials Group
Country [1] 623 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group Ltd
Address
PO Box 155
HRMC NSW 2310
Country
Australia
Secondary sponsor category [1] 508 0
Other Collaborative groups
Name [1] 508 0
International Breast Cancer Study Group
Address [1] 508 0
Effingerstrasse 40
3008 Bern
Country [1] 508 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1744 0
Border Medical Oncology
Ethics committee address [1] 1744 0
Ethics committee country [1] 1744 0
Australia
Date submitted for ethics approval [1] 1744 0
Approval date [1] 1744 0
17/08/2005
Ethics approval number [1] 1744 0

Summary
Brief summary
For further information, please see www.clinicaltrials.gov NCT00066573
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35654 0
Prof John F Forbes
Address 35654 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35654 0
Australia
Phone 35654 0
+61 2 4985 0113
Fax 35654 0
Email 35654 0
[email protected]
Contact person for public queries
Name 9620 0
Ms Corinna Beckmore
Address 9620 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 9620 0
Australia
Phone 9620 0
+61 2 4925 3068
Fax 9620 0
+61 2 49850141
Email 9620 0
[email protected]
Contact person for scientific queries
Name 548 0
Prof John F Forbes
Address 548 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 548 0
Australia
Phone 548 0
+61 2 49850113
Fax 548 0
+61 2 49601539
Email 548 0
[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
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