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Trial registered on ANZCTR


Registration number
ACTRN12605000418673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
9/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial
Scientific title
IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial A phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer.
Secondary ID [1] 167 0
National Clinical Trials Registry: NCTR584
Universal Trial Number (UTN)
Trial acronym
TEXT Tamoxifen and Exemestane
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 527 0
Condition category
Condition code
Cancer 607 607 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IBCSG 25-02 / BIG 3-02 (TEXT) is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by the Australian and New Zealand Breast Cancer Trials Group (ANZ BCTG).

This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated.

IBCSG 25-02 / BIG 3-02 (TEXT) is an international, multicentre, randomised phase III clinical trial of 1850 premenopausal 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. Ovarian Function Suppression (triptorelin) + Tamoxifen
b. Ovarian Function Suppression (triptorelin) + Exemestane


All treatment will be for 5 years.
Intervention code [1] 489 0
Treatment: Drugs
Comparator / control treatment
Arm A - Tamoxifen as the control treatment: 20mg given orally daily until 5yrs from date of randomisation, unless relapse or intolerance should occur earlier. Triptorelin 3.75mg given by intramuscular injection every 28 days for 5 years from randomisation, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.
Control group
Active

Outcomes
Primary outcome [1] 707 0
Disease free survival (DFS) - defined as the time from randomisation to local (including recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) primary tumour, or death from any cause, whichever occurs first. An appearance of ductal carcinoma in-situ (DCIS) or lobular carcinoma in-situ (LCIS) either in the ipsilateral or in the contralateral breast will not be considered as an event for DFS.
Timepoint [1] 707 0
Disease free survival (DFS) - DFS will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [1] 1451 0
Overall survival
Timepoint [1] 1451 0
Overall survival will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [2] 1452 0
Systemic disease-free survival
Timepoint [2] 1452 0
Systemic disease-free survival will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [3] 1453 0
Quality of life
Timepoint [3] 1453 0
Quality of life will be assessed at baseline, then at months 6, 12, 18, 24, 36, 48, 60 and 72. The primary analyses will be based on treatment differences at each QL assessment time point.
Secondary outcome [4] 1454 0
Sites of first treatment failure
Timepoint [4] 1454 0
Sites of first treatment failure will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [5] 1455 0
Late side effects of early menopause
Timepoint [5] 1455 0
Late side effects of early menopause will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [6] 1456 0
Incidence of second (non-breast) malignancies
Timepoint [6] 1456 0
Incidence of second (non-breast) malignancies will be assessed assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.
Secondary outcome [7] 1457 0
Causes of death without cancer event between the treatment arms.
Timepoint [7] 1457 0
Causes of death without cancer event between the treatment arms will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.

Eligibility
Key inclusion criteria
Pre-menopausal women with histologically proven, completely resected hormone receptor positive breast cancer confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy is required; geographically accessible for follow up; written informed consent provided.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Post-menopausal women; distant metastatic disease; locally advanced inoperable breast cancer; supraclavicular node involvement; enlarged internal mammary nodes; bilateral invasive breast cancer; positive final margins; clinically detectable residual axillary disease; history of prior ipsilateral or contralateral invasive breast cancer; previous or concomitant malignancy; other non-malignant systemic diseases that would prevent prolonged follow-up; bilateral oophorectomy or ovarian irradiation; pregnant or lactating at randomisation, desire a pregnancy within 5 years or plan to use additional hormone therapy during next 5 years (including hormonal contraception); neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; prior neoadjuvant or adjuvant chemotherapy.

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)
Computer generated stratified blocks
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 663 0
Self funded/Unfunded
Name [1] 663 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 663 0
PO Box 155
Hunter Region Mail Centre NSW 2310
Country [1] 663 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
PO Box 155
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 553 0
Other Collaborative groups
Name [1] 553 0
International Breast Cancer Study Group
Address [1] 553 0
IBCSG Coordinating Center
Effingerstrasse 40
3008 Bern
SWITZERLAND
Country [1] 553 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1827 0
The Alfred Hospital
Ethics committee address [1] 1827 0
Ethics committee country [1] 1827 0
Australia
Date submitted for ethics approval [1] 1827 0
Approval date [1] 1827 0
01/10/2005
Ethics approval number [1] 1827 0
Ethics committee name [2] 1828 0
Austin Health
Ethics committee address [2] 1828 0
Ethics committee country [2] 1828 0
Australia
Date submitted for ethics approval [2] 1828 0
Approval date [2] 1828 0
01/09/2005
Ethics approval number [2] 1828 0
Ethics committee name [3] 1829 0
Box Hill Hospital
Ethics committee address [3] 1829 0
Ethics committee country [3] 1829 0
Australia
Date submitted for ethics approval [3] 1829 0
Approval date [3] 1829 0
01/07/2005
Ethics approval number [3] 1829 0
Ethics committee name [4] 1830 0
Liverpool Hospital
Ethics committee address [4] 1830 0
Ethics committee country [4] 1830 0
Australia
Date submitted for ethics approval [4] 1830 0
Approval date [4] 1830 0
01/06/2005
Ethics approval number [4] 1830 0
Ethics committee name [5] 1831 0
Macarthur Cancer Therapy Centre
Ethics committee address [5] 1831 0
Ethics committee country [5] 1831 0
Australia
Date submitted for ethics approval [5] 1831 0
Approval date [5] 1831 0
01/06/2005
Ethics approval number [5] 1831 0
Ethics committee name [6] 1832 0
Maroondah Hospital
Ethics committee address [6] 1832 0
Ethics committee country [6] 1832 0
Australia
Date submitted for ethics approval [6] 1832 0
Approval date [6] 1832 0
01/06/2005
Ethics approval number [6] 1832 0
Ethics committee name [7] 1833 0
St Vincents and Mercy Private
Ethics committee address [7] 1833 0
Ethics committee country [7] 1833 0
Australia
Date submitted for ethics approval [7] 1833 0
Approval date [7] 1833 0
01/01/2006
Ethics approval number [7] 1833 0
Ethics committee name [8] 1834 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [8] 1834 0
Ethics committee country [8] 1834 0
Australia
Date submitted for ethics approval [8] 1834 0
Approval date [8] 1834 0
01/09/2005
Ethics approval number [8] 1834 0
Ethics committee name [9] 1835 0
Peter MacCallum Cancer Centre
Ethics committee address [9] 1835 0
Ethics committee country [9] 1835 0
Australia
Date submitted for ethics approval [9] 1835 0
Approval date [9] 1835 0
01/11/2004
Ethics approval number [9] 1835 0
Ethics committee name [10] 1836 0
Riverina Cancer Care Centre
Ethics committee address [10] 1836 0
Ethics committee country [10] 1836 0
Australia
Date submitted for ethics approval [10] 1836 0
Approval date [10] 1836 0
01/07/2005
Ethics approval number [10] 1836 0
Ethics committee name [11] 1837 0
Royal Brisbane and Womens Hospital
Ethics committee address [11] 1837 0
Ethics committee country [11] 1837 0
Australia
Date submitted for ethics approval [11] 1837 0
Approval date [11] 1837 0
01/02/2005
Ethics approval number [11] 1837 0
Ethics committee name [12] 1838 0
Royal Hobart Hospital
Ethics committee address [12] 1838 0
Ethics committee country [12] 1838 0
Australia
Date submitted for ethics approval [12] 1838 0
Approval date [12] 1838 0
01/04/2005
Ethics approval number [12] 1838 0
Ethics committee name [13] 1839 0
Royal Perth Hospital
Ethics committee address [13] 1839 0
Ethics committee country [13] 1839 0
Australia
Date submitted for ethics approval [13] 1839 0
Approval date [13] 1839 0
01/11/2004
Ethics approval number [13] 1839 0

Summary
Brief summary
Research has shown that exemestane works better in postmenopausal women because their ovaries are no longer producing oestrogen. TEXT will determine if suppressing ovarian function in premenopausal women (i.e. reducing oestrogen production) will allow exemestane to work in the same way as it does for postmeopausal women. This trial is designed for participants who should receive ovarian function suppression from the start of their adjuvant breast cancer treatment.
Trial website
www.anzbctg.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35154 0
Prof John F. Forbes
Address 35154 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35154 0
Australia
Phone 35154 0
+61 2 4925 5235
Fax 35154 0
Email 35154 0
enquiries@anzbctg.org
Contact person for public queries
Name 9678 0
Prof Australia and New Zealand Breast Cancer Trials Group
Address 9678 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 9678 0
Australia
Phone 9678 0
+61 2 4925 3068
Fax 9678 0
+61 2 49850141
Email 9678 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 606 0
Prof John F. Forbes
Address 606 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 606 0
Australia
Phone 606 0
+61 2 4925 3068
Fax 606 0
+61 2 49850141
Email 606 0
enquiries@anzbctg.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary