Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000033448
Ethics application status
Approved
Date submitted
20/03/1998
Date registered
20/03/1998
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Intergroup Exemestane Study (IES)
Scientific title
Randomised double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen
Secondary ID [1] 16 0
National Clinical Trials Registry: NCTR220
Secondary ID [2] 17 0
Pfizer: 96-OEXE-031
Secondary ID [3] 287870 0
ISRCTN11883920
Secondary ID [4] 287871 0
NCT00003418
Universal Trial Number (UTN)
Trial acronym
IES / IBCSG 16-98 / BIG 2-97
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 16 0
Condition category
Condition code
Cancer 16 16 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to compare the following treatment arms:
* Exemestane 25mg/day orally for 2-3 years
* Tamoxifen 20mg/day orally for 2-3 years.

Treatment on study is given following 2-3 years of treatment with tamoxifen. The overall duration of endocrine treatment is 5 years.
Intervention code [1] 1290 0
Treatment: Drugs
Comparator / control treatment
See Description of interventions above (Please note, study closed to recruitment in 2003).
Control group
Active

Outcomes
Primary outcome [1] 31 0
Disease Free Survival (DFS).

Disease progression is defined as the appearance of local or distant metastases at any site.
Timepoint [1] 31 0
Patients are assessed by the clinician for progression of disease 3 monhtly in the first year, 6 monthly in years 2 - 4 and annually thereafter to year 10 from randomisation.
Secondary outcome [1] 48 0
Overall survival
Timepoint [1] 48 0
Patients are assessed by clinicians for overall survival, incidence of second breast cancer 3 monthly in the first year, 6 monthly for years 2-4 and yearly thereafter until year 10 from randomisation.
Secondary outcome [2] 49 0
Incidence of second breast cancer (in contralateral breast).
Timepoint [2] 49 0
Three interim analyses will be performed when 1/4, 2/4 and 3/4 of the total required events (total = 716) have occurred, respectively.

Events are defined as recurrence, second primary and/or death.
Secondary outcome [3] 50 0
Long term tolerability of the regimens
Timepoint [3] 50 0
Monitoring of tolerability including side-effects and death rate, for all randomised patients, will be performed at approximately yearly intervals until year 10 from randomisation.
Secondary outcome [4] 51 0
Quality of life (in selected centres).
Timepoint [4] 51 0
Quality of Life is assessed 3 monthly in the first year, 6 monthly years 2-4 and then once at the the end of 5 years on study. Quality of Life is also assessed at one month post-randomisation.
Secondary outcome [5] 52 0
Saftey Profile in regards to bone metabolism and endometrial status (in selected centres).
Timepoint [5] 52 0
Assessed 3 monthly in the first year, 6 monthly years 2-4 and then once at the the end of 5 years on study

Eligibility
Key inclusion criteria
At breast cancer diagnosis, patients must have: histologically or cytologically confirmed unilateral adenocarcinoma of the breast which was considered "operable". ER status positive or unknown. Have had adequate therapy for primary disease. At randomisation patients must: Be postmenopausal as defined by: any patient > or equal to 55 and ammenorrhoea for > 2 years or, radiation menopause (at least 3 months previously) or surgical oophorectomy or, natural amenorrhoea > or equal to 1 year at breast cancer diagnosis. At randomisation, patients must be receiving tamoxifen and have been treated with tamoxifen for between 2 and 3 years (dose = 20mg/d, unless otherwise agreed with Pharmacia and Upjohn before joining the study) with no more than one month break at any time.Remain free from disease following treatment for primary disease. Have adequate haematological, renal and hepatic function. Be accessible for follow-up for the duration of the trial. Have given written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No longer available - study closed to recruitment in 2003.

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 Australian New Zealand Breast Cancer Trials Group 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 the patients) are blinded
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/1998
Actual
17/08/1998
Date of last participant enrolment
Anticipated
Actual
1/02/2003
Date of last data collection
Anticipated
Actual
Sample size
Target
4400
Accrual to date
Final
4743
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 19 0
Self funded/Unfunded
Name [1] 19 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 19 0
Australia
Funding source category [2] 20 0
Commercial sector/Industry
Name [2] 20 0
Pfizer
Country [2] 20 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pharmacia and Upjohn (now merged as part of Pfizer)
Address
235 East 42nd Street
NY, NY 10017
Country
United States of America
Secondary sponsor category [1] 16 0
Other Collaborative groups
Name [1] 16 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 16 0
PO BOX 155
HRMC NSW 2310
Country [1] 16 0
Australia
Secondary sponsor category [2] 17 0
Other Collaborative groups
Name [2] 17 0
International Breast Cancer Study Group
Address [2] 17 0
Effingerstrasse 40, 3008 Bern
Country [2] 17 0
Switzerland
Secondary sponsor category [3] 18 0
Other Collaborative groups
Name [3] 18 0
International Collaborative Cancer Group (ICCG)
Address [3] 18 0
Effingerstrasse 40, 3008 Bern
Country [3] 18 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 204 0
Auckland Hospital
Ethics committee address [1] 204 0
Ethics committee country [1] 204 0
New Zealand
Date submitted for ethics approval [1] 204 0
Approval date [1] 204 0
Ethics approval number [1] 204 0
Ethics committee name [2] 205 0
Bendigo Hospital
Ethics committee address [2] 205 0
Ethics committee country [2] 205 0
Australia
Date submitted for ethics approval [2] 205 0
Approval date [2] 205 0
Ethics approval number [2] 205 0
Ethics committee name [3] 206 0
Box Hill Hospital
Ethics committee address [3] 206 0
Ethics committee country [3] 206 0
Australia
Date submitted for ethics approval [3] 206 0
Approval date [3] 206 0
Ethics approval number [3] 206 0
Ethics committee name [4] 207 0
Dubbo Base Hospital
Ethics committee address [4] 207 0
Ethics committee country [4] 207 0
Australia
Date submitted for ethics approval [4] 207 0
Approval date [4] 207 0
Ethics approval number [4] 207 0
Ethics committee name [5] 208 0
Liverpool Hospital
Ethics committee address [5] 208 0
Ethics committee country [5] 208 0
Australia
Date submitted for ethics approval [5] 208 0
Approval date [5] 208 0
Ethics approval number [5] 208 0
Ethics committee name [6] 209 0
Maroondah Hospital
Ethics committee address [6] 209 0
Ethics committee country [6] 209 0
Australia
Date submitted for ethics approval [6] 209 0
Approval date [6] 209 0
Ethics approval number [6] 209 0
Ethics committee name [7] 210 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [7] 210 0
Ethics committee country [7] 210 0
Australia
Date submitted for ethics approval [7] 210 0
Approval date [7] 210 0
Ethics approval number [7] 210 0
Ethics committee name [8] 211 0
Royal Adelaide Hospital
Ethics committee address [8] 211 0
Ethics committee country [8] 211 0
Australia
Date submitted for ethics approval [8] 211 0
Approval date [8] 211 0
Ethics approval number [8] 211 0
Ethics committee name [9] 212 0
Royal Prince Alfred Hospital
Ethics committee address [9] 212 0
Ethics committee country [9] 212 0
Australia
Date submitted for ethics approval [9] 212 0
Approval date [9] 212 0
01/11/1997
Ethics approval number [9] 212 0
Ethics committee name [10] 213 0
Waikato Hospital
Ethics committee address [10] 213 0
Ethics committee country [10] 213 0
New Zealand
Date submitted for ethics approval [10] 213 0
Approval date [10] 213 0
Ethics approval number [10] 213 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35129 0
Prof John F Forbes
Address 35129 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35129 0
Australia
Phone 35129 0
+61 2 4985 0113
Fax 35129 0
Email 35129 0
enquiries@anzbctg.org
Contact person for public queries
Name 10479 0
Corinna Beckmore
Address 10479 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10479 0
Australia
Phone 10479 0
+61 2 4925 3068
Fax 10479 0
+61 2 49850141
Email 10479 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 1407 0
John F Forbes
Address 1407 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1407 0
Australia
Phone 1407 0
+61 2 4985 0113
Fax 1407 0
+ 61 2 4960 1539
Email 1407 0
enquiries@anzbctg.org

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

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Documents added automatically
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