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Trial registered on ANZCTR


Registration number
ACTRN12605000419662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
19/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
IBCSG 26-02 / BIG 4-02: Premenopausal Endocrine Responsive Chemotherapy Trial
Scientific title
IBCSG 26-02 / BIG 4-02: Premenopausal Endocrine Responsive Chemotherapy Trial A phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine responsive breast cancer who receive endocrine therapy.
Secondary ID [1] 168 0
National Clinical Trials Registry: NCTR585
Universal Trial Number (UTN)
Trial acronym
PERCHE Premenopausal Endocrin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 528 0
Condition category
Condition code
Cancer 608 608 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IBCSG 26-02 / BIG 4-02 (PERCHE) 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 adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for 5 years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for 5 years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator.

IBCSG 26-02 / BIG 4-02 (PERCHE) is an international, multicentre, randomised phase III clinical trial of 1750 premenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program.

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

a. Chemotherapy + Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane
b. Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane
All hormonal treatment will be for 5 years.
Intervention code [1] 490 0
Treatment: Drugs
Comparator / control treatment
a. Chemotherapy + Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane
b. Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane
All hormonal treatment will be for 5 years.
Control group
Active

Outcomes
Primary outcome [1] 708 0
To compare disease free survival between treatment arms.
Timepoint [1] 708 0
At first confirmation of relapse (local, regional or distant), contralateral breast cancer, second (non-breast) primary tumour and/death.
Secondary outcome [1] 1459 0
To compare overall survival
Timepoint [1] 1459 0
At time of death from any cause
Secondary outcome [2] 1460 0
Systemic disease-free survival
Timepoint [2] 1460 0
At the time of systemic relapse, appearance of second (non-breast) primary tumour, or death, whichever occurs first.
Secondary outcome [3] 1461 0
Quality of life
Timepoint [3] 1461 0
6 years
Secondary outcome [4] 1462 0
Sites of first treatment failure
Timepoint [4] 1462 0
At the time of first treatment failure.
Secondary outcome [5] 1463 0
Late side effects of early menopause
Timepoint [5] 1463 0
At the time of menopause.
Secondary outcome [6] 1464 0
Incidence of second (non-breast) malignancies
Timepoint [6] 1464 0
At the time of incidence of second (non-breast) malignancies
Secondary outcome [7] 1465 0
Causes of death without cancer event between the treatment arms.
Timepoint [7] 1465 0
At the time of death

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
Sex
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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
22/11/2004
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
31/10/2006
Date of last data collection
Anticipated
Actual
18/09/2015
Sample size
Target
1750
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment outside Australia
Country [1] 8331 0
New Zealand
State/province [1] 8331 0

Funding & Sponsors
Funding source category [1] 664 0
Self funded/Unfunded
Name [1] 664 0
ANZ Breast Cancer Trials Group
Country [1] 664 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] 554 0
Other Collaborative groups
Name [1] 554 0
International Breast Cancer Study Group
Address [1] 554 0
Effingerstrasse 40
3008 Bern
Country [1] 554 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1840 0
Box Hill Hospital
Ethics committee address [1] 1840 0
Ethics committee country [1] 1840 0
Australia
Date submitted for ethics approval [1] 1840 0
Approval date [1] 1840 0
Ethics approval number [1] 1840 0
Ethics committee name [2] 1841 0
Maroondah Hospital
Ethics committee address [2] 1841 0
Ethics committee country [2] 1841 0
Australia
Date submitted for ethics approval [2] 1841 0
Approval date [2] 1841 0
Ethics approval number [2] 1841 0
Ethics committee name [3] 1842 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [3] 1842 0
Ethics committee country [3] 1842 0
Australia
Date submitted for ethics approval [3] 1842 0
Approval date [3] 1842 0
Ethics approval number [3] 1842 0
Ethics committee name [4] 1843 0
Peter MacCallum Cancer Centre
Ethics committee address [4] 1843 0
Ethics committee country [4] 1843 0
Australia
Date submitted for ethics approval [4] 1843 0
Approval date [4] 1843 0
01/11/2004
Ethics approval number [4] 1843 0
Ethics committee name [5] 1844 0
Riverina Cancer Care Centre
Ethics committee address [5] 1844 0
Ethics committee country [5] 1844 0
Australia
Date submitted for ethics approval [5] 1844 0
Approval date [5] 1844 0
Ethics approval number [5] 1844 0
Ethics committee name [6] 1845 0
Royal Hobart Hospital
Ethics committee address [6] 1845 0
Ethics committee country [6] 1845 0
Australia
Date submitted for ethics approval [6] 1845 0
Approval date [6] 1845 0
Ethics approval number [6] 1845 0

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

Contacts
Principal investigator
Name 36120 0
A/Prof Prue Francis
Address 36120 0
Medical Oncology Department
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
MELBOURNE VIC 8006
Country 36120 0
Australia
Phone 36120 0
+61 (03) 9656-1111
Fax 36120 0
Email 36120 0
[email protected]
Contact person for public queries
Name 9679 0
Corinna Beckmore
Address 9679 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 9679 0
Australia
Phone 9679 0
+61 2 4925 3068
Fax 9679 0
+61 2 49850141
Email 9679 0
[email protected]
Contact person for scientific queries
Name 607 0
John F Forbes
Address 607 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 607 0
Australia
Phone 607 0
+61 2 49850113
Fax 607 0
+61 2 49601539
Email 607 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

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