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Trial registered on ANZCTR


Registration number
ACTRN12605000357651
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
11/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
SNAC Trial
Scientific title
A randomised phase III study to determine in women with early breast cancer whether sentinel node biopsy and axillary clearance if positive, results in less morbidity than immediate axillary clearance with equivalent cancer-related outcomes.
Universal Trial Number (UTN)
Trial acronym
SNAC Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Operable breast cancer 451 0
Condition category
Condition code
Cancer 528 528 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sentinel node biopsy with immediate standard axillary clearance vs sentinel node biopsy alone with axillary clearance if sentinel node is not identified or sentinel node is positive for cancer.
Intervention code [1] 396 0
Treatment: Surgery
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 606 0
Early axillary morbidity
Timepoint [1] 606 0
Measured at baseline, one month after definitive axillary surgery, 6 months after randomisation and annually for 5 years.
Primary outcome [2] 607 0
Observer ratings of arm swelling, shoulder movement, sensation
Timepoint [2] 607 0
Measured at baseline, one month after definitive axillary surgery, 6 months after randomisation and annually for 5 years.
Primary outcome [3] 608 0
QOL ratings
Timepoint [3] 608 0
Measured at baseline, one month after definitive axillary surgery, 6 months after randomisation and annually for 5 years.
Secondary outcome [1] 1269 0
1. Axillary recurrence rates
Timepoint [1] 1269 0
Measured 1 month post definitive axillary surgery, 6 months after randomisation, and annually for at least 10 years.
Secondary outcome [2] 1270 0
2. Relapse free survival and overall survival
Timepoint [2] 1270 0
Measured 1 month post definitive axillary surgery, 6 months after randomisation, and annually for at least 10 years.
Secondary outcome [3] 1271 0
3. Use of adjuvant radiation therapy, chemotherapy and endocrine therapy.
Timepoint [3] 1271 0
Measured at 1 year post randomisation.
Secondary outcome [4] 1272 0
4.Number of surgical episodes and days in hospital.
Timepoint [4] 1272 0
Measured 1 month post randomisation, 6 months post randomisation and yearly for 5 years.

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed invasive breast cancer.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
In situ cancer only. Clinically involved nodes where axillary surgery is deemed essential. Multicentric tumours. Primary tumour >3cm in diameter. Evidence of metastatic disease.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Oracle computer software was used to generate the random allocation sequence. In addition minimisation and stratification of prognostic factors was used.
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
Active, not recruiting
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] 587 0
Name [1] 587 0
Address [1] 587 0
Country [1] 587 0
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 476 0
Charities/Societies/Foundations
Name [1] 476 0
NBCF
Address [1] 476 0
Country [1] 476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1612 0
Prince Alfred Hospital
Ethics committee address [1] 1612 0
Ethics committee country [1] 1612 0
Australia
Date submitted for ethics approval [1] 1612 0
Approval date [1] 1612 0
Ethics approval number [1] 1612 0
Ethics committee name [2] 1613 0
Westmead Hospital
Ethics committee address [2] 1613 0
Ethics committee country [2] 1613 0
Australia
Date submitted for ethics approval [2] 1613 0
Approval date [2] 1613 0
Ethics approval number [2] 1613 0
Ethics committee name [3] 1614 0
Concord Hospital
Ethics committee address [3] 1614 0
Ethics committee country [3] 1614 0
Australia
Date submitted for ethics approval [3] 1614 0
Approval date [3] 1614 0
Ethics approval number [3] 1614 0
Ethics committee name [4] 1615 0
Coffs Harbour Base Hospital
Ethics committee address [4] 1615 0
Ethics committee country [4] 1615 0
Australia
Date submitted for ethics approval [4] 1615 0
Approval date [4] 1615 0
Ethics approval number [4] 1615 0
Ethics committee name [5] 1616 0
Nepean Hospital
Ethics committee address [5] 1616 0
Ethics committee country [5] 1616 0
Australia
Date submitted for ethics approval [5] 1616 0
Approval date [5] 1616 0
Ethics approval number [5] 1616 0
Ethics committee name [6] 1617 0
St Vincent's Mater Hospital, Sydney
Ethics committee address [6] 1617 0
Ethics committee country [6] 1617 0
Australia
Date submitted for ethics approval [6] 1617 0
Approval date [6] 1617 0
Ethics approval number [6] 1617 0
Ethics committee name [7] 1618 0
Strathfield Breast Centre
Ethics committee address [7] 1618 0
Ethics committee country [7] 1618 0
Australia
Date submitted for ethics approval [7] 1618 0
Approval date [7] 1618 0
Ethics approval number [7] 1618 0
Ethics committee name [8] 1619 0
Baringa Private Hospital
Ethics committee address [8] 1619 0
Ethics committee country [8] 1619 0
Australia
Date submitted for ethics approval [8] 1619 0
Approval date [8] 1619 0
Ethics approval number [8] 1619 0
Ethics committee name [9] 1620 0
Royal Melbourne Hospital
Ethics committee address [9] 1620 0
Ethics committee country [9] 1620 0
Australia
Date submitted for ethics approval [9] 1620 0
Approval date [9] 1620 0
Ethics approval number [9] 1620 0
Ethics committee name [10] 1621 0
St Vincent's Hospital
Ethics committee address [10] 1621 0
Ethics committee country [10] 1621 0
Australia
Date submitted for ethics approval [10] 1621 0
Approval date [10] 1621 0
Ethics approval number [10] 1621 0
Ethics committee name [11] 1622 0
Geelong Hospital
Ethics committee address [11] 1622 0
Ethics committee country [11] 1622 0
Australia
Date submitted for ethics approval [11] 1622 0
Approval date [11] 1622 0
Ethics approval number [11] 1622 0
Ethics committee name [12] 1623 0
Royal Women's Hospital
Ethics committee address [12] 1623 0
Ethics committee country [12] 1623 0
Australia
Date submitted for ethics approval [12] 1623 0
Approval date [12] 1623 0
Ethics approval number [12] 1623 0
Ethics committee name [13] 1624 0
Princess Alexandra Hospital
Ethics committee address [13] 1624 0
Ethics committee country [13] 1624 0
Australia
Date submitted for ethics approval [13] 1624 0
Approval date [13] 1624 0
Ethics approval number [13] 1624 0
Ethics committee name [14] 1625 0
Mater Private Hospital, Brisbane
Ethics committee address [14] 1625 0
Ethics committee country [14] 1625 0
Australia
Date submitted for ethics approval [14] 1625 0
Approval date [14] 1625 0
Ethics approval number [14] 1625 0
Ethics committee name [15] 1626 0
Nambour General Hospital
Ethics committee address [15] 1626 0
Ethics committee country [15] 1626 0
Australia
Date submitted for ethics approval [15] 1626 0
Approval date [15] 1626 0
Ethics approval number [15] 1626 0
Ethics committee name [16] 1627 0
Wesley Medical Centre
Ethics committee address [16] 1627 0
Ethics committee country [16] 1627 0
Australia
Date submitted for ethics approval [16] 1627 0
Approval date [16] 1627 0
Ethics approval number [16] 1627 0
Ethics committee name [17] 1628 0
Mater Adult Hospital
Ethics committee address [17] 1628 0
Ethics committee country [17] 1628 0
Australia
Date submitted for ethics approval [17] 1628 0
Approval date [17] 1628 0
Ethics approval number [17] 1628 0
Ethics committee name [18] 1629 0
Royal Adelaide Hospital
Ethics committee address [18] 1629 0
Ethics committee country [18] 1629 0
Australia
Date submitted for ethics approval [18] 1629 0
Approval date [18] 1629 0
Ethics approval number [18] 1629 0
Ethics committee name [19] 1630 0
St Andrew's Hospital
Ethics committee address [19] 1630 0
Ethics committee country [19] 1630 0
Australia
Date submitted for ethics approval [19] 1630 0
Approval date [19] 1630 0
Ethics approval number [19] 1630 0
Ethics committee name [20] 1631 0
Queen Elizabeth Hospital
Ethics committee address [20] 1631 0
Ethics committee country [20] 1631 0
Australia
Date submitted for ethics approval [20] 1631 0
Approval date [20] 1631 0
Ethics approval number [20] 1631 0
Ethics committee name [21] 1632 0
Western Breast Clinic
Ethics committee address [21] 1632 0
Ethics committee country [21] 1632 0
Australia
Date submitted for ethics approval [21] 1632 0
Approval date [21] 1632 0
Ethics approval number [21] 1632 0
Ethics committee name [22] 1633 0
Sir Charles Gairdner Hospital
Ethics committee address [22] 1633 0
Ethics committee country [22] 1633 0
Australia
Date submitted for ethics approval [22] 1633 0
Approval date [22] 1633 0
Ethics approval number [22] 1633 0
Ethics committee name [23] 1634 0
Middlemore Hospital
Ethics committee address [23] 1634 0
Ethics committee country [23] 1634 0
New Zealand
Date submitted for ethics approval [23] 1634 0
Approval date [23] 1634 0
Ethics approval number [23] 1634 0
Ethics committee name [24] 1635 0
North Shore Hospital
Ethics committee address [24] 1635 0
Ethics committee country [24] 1635 0
New Zealand
Date submitted for ethics approval [24] 1635 0
Approval date [24] 1635 0
Ethics approval number [24] 1635 0
Ethics committee name [25] 1636 0
Waikato Hospital
Ethics committee address [25] 1636 0
Ethics committee country [25] 1636 0
New Zealand
Date submitted for ethics approval [25] 1636 0
Approval date [25] 1636 0
Ethics approval number [25] 1636 0
Ethics committee name [26] 1637 0
Palmerston North Hospital
Ethics committee address [26] 1637 0
Ethics committee country [26] 1637 0
New Zealand
Date submitted for ethics approval [26] 1637 0
Approval date [26] 1637 0
Ethics approval number [26] 1637 0
Ethics committee name [27] 1638 0
Auckland Hospital
Ethics committee address [27] 1638 0
Ethics committee country [27] 1638 0
New Zealand
Date submitted for ethics approval [27] 1638 0
Approval date [27] 1638 0
Ethics approval number [27] 1638 0
Ethics committee name [28] 1639 0
St John of God Hospital, Murdoch
Ethics committee address [28] 1639 0
Ethics committee country [28] 1639 0
Australia
Date submitted for ethics approval [28] 1639 0
Approval date [28] 1639 0
Ethics approval number [28] 1639 0
Ethics committee name [29] 1640 0
St Vincent's Private Hospital
Ethics committee address [29] 1640 0
Lismore NSW
Ethics committee country [29] 1640 0
Australia
Date submitted for ethics approval [29] 1640 0
Approval date [29] 1640 0
Ethics approval number [29] 1640 0
Ethics committee name [30] 1641 0
Lismore Base Hospital
Ethics committee address [30] 1641 0
Ethics committee country [30] 1641 0
Australia
Date submitted for ethics approval [30] 1641 0
Approval date [30] 1641 0
Ethics approval number [30] 1641 0
Ethics committee name [31] 1642 0
Gold Coast Hospital
Ethics committee address [31] 1642 0
Ethics committee country [31] 1642 0
Australia
Date submitted for ethics approval [31] 1642 0
Approval date [31] 1642 0
Ethics approval number [31] 1642 0

Summary
Brief summary
There are 32 active sites.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35404 0
Address 35404 0
Country 35404 0
Phone 35404 0
Fax 35404 0
Email 35404 0
Contact person for public queries
Name 9585 0
Associate Professor Grantley Gill (Study Chair)
Address 9585 0
Breast Endocrine
Surgical Oncology Unit
The University of Adelaide
North Terrace Campus
Level 6
East Wing Link
Adelaide SA 5000
Country 9585 0
Australia
Phone 9585 0
+61 8 82224154
Fax 9585 0
+61 8 82326761
Email 9585 0
grantley.gill@adelaide.edu.au
Contact person for scientific queries
Name 513 0
Xanthi Coskinas
Address 513 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked bag 77
Camperdown NSW 1450
Country 513 0
Australia
Phone 513 0
+61 2 95625049
Fax 513 0
+61 2 95625094
Email 513 0
xanthi.coskinas@ctc.usyd.edu.au

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