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Trial registered on ANZCTR


Trial ID
ACTRN12605000409673
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
15/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
SNAC2: A randomised phase III study to determine in women with early breast cancer whether sentinel node based management increases the risk of loco-regional recurrence and in particular, axillary clearance, compared with axillary clearance with any subgroup of women
Scientific title
A randomised phase III study to determine in women with early breast cancer whether sentinel node based management increases the risk of loco-regional recurrence and in particular, axillary recurrence, compared with axillary clearance in any subgroup of women
Universal Trial Number (UTN)
Trial acronym
SNAC2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Operable early breast cancer 517 0
Condition category
Condition code
Cancer 594 594 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sentinel biopsy alone with axillary clearance if sentinel node is not identified or sentinel node is positive for cancer. Sentinel node biopsy is a new surgical procedure. A sentinel node biopsy means surgery to remove the sentinel lymph node or nodes. There can be more than one sentinel node. The sentinel node is the first lymph node that breast cancer cells may spread to outside the breast.
Intervention code [1] 432 0
Treatment: surgery
Comparator / control treatment
Sentinel node biopsy with immediate standard axillary clearance. Standard axillary clearance- It involves the removal of most of the lymph nodes or glands in the armpit of the affected side and a pathologist looking for any cancer cells which may have spread from the breast cancer.
Control group
Active

Outcomes
Primary outcome [1] 690 0
To determine if sentinel node based management increases the risk of loco-regional recurrence compared with axillary clearance in any subgroup of women
Timepoint [1] 690 0
Assessed at 1 month post definitive axillary surgery, 6 months after randomisaton and yearly for 10 years after randomisation.
Secondary outcome [1] 1426 0
If sentinel node based management affects overall survival or distant disease free survival.
Timepoint [1] 1426 0
Patient status will be measured at 6 months after randomisation and yearly for 10 years after randomisation.
Secondary outcome [2] 1427 0
The outcomes of SNB vs AC in the subgroup of women with negative SNB.
Timepoint [2] 1427 0
Patient status will be measured at 6 months after randomisation and yearly for 10 years after randomisation.
Secondary outcome [3] 1428 0
SNB negative rates for those randomised to SNB vs those randomised to AC.
Timepoint [3] 1428 0
Pathology status of sentinel node will be assessed following sentinel node biopsy vs pathology status of sentinel node following sentinel node biopsy and axillary clearance.
Secondary outcome [4] 1429 0
Variations among centres in the diagnostic accuracy of SNB among those randomised to AC who have a negative SNB:
Timepoint [4] 1429 0
Variations among centres will be assessed following sentinel node biopsy and axillary clearance where the sentinel node biopsy result is negative.
Secondary outcome [5] 1430 0
The clinical and pathological features that may predict risk of a false negative sentinel node:
Timepoint [5] 1430 0
Patients clinical features will be assessed prior to the sentinel node biopsy and pathological features of the sentinel node will be assessed following sentinel node biopsy and axillary clearance.

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed invasive breast cancer.Single or multiple ipsilateral primary breast cancer(s)Primary breast cancer may be less than or greater than 3cm.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
In situ carcinoma only, clinically involved nodes where the investigator deems axillary clearance is essential, evidence of metastatic disease,previous breast cancer or in-situ carcinoma in the same breast.

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)
Computer generated -Minimisation, stratification
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

Recruitment
Recruitment status
Recruiting
Anticipated date of first participant enrolment
18/07/2006
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
1012
Actual sample size
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 194 0
New Zealand
State/province [1] 194 0

Funding & Sponsors
Funding source category [1] 648 0
Government body
Name [1] 648 0
National Health and Medical Research Council
Address [1] 648 0
Canberra
Country [1] 648 0
Australia
Funding source category [2] 2863 0
Charities/Societies/Foundations
Name [2] 2863 0
New Zealand Cancer Society
Address [2] 2863 0
Wakefield House
90 The Terrace
PO Box 10847
Wellington New Zealand
Country [2] 2863 0
New Zealand
Funding source category [3] 2884 0
Government body
Name [3] 2884 0
Multi-state Cancer Council funding
Address [3] 2884 0
Queensland, South Australia, New South Wales, Victoria
Country [3] 2884 0
Australia
Primary sponsor type
Government body
Name
National Health & Medical Research Council (NHMRC)
Address
88 Mallett St
Campderdown NSW 2050
Country
Australia
Secondary sponsor category [1] 544 0
None
Name [1] 544 0
Address [1] 544 0
Country [1] 544 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
http://www.ctc.usyd.edu.au/trials/cancer/breast.htm
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35369 0
Address 35369 0
Country 35369 0
Phone 35369 0
Fax 35369 0
Email 35369 0
Contact person for public queries
Name 9621 0
Dr Ian Campbell (Study Chair)
Address 9621 0
Department of Surgery
Waikato Hospital
Private Bag 3200
Hamilton
Country 9621 0
New Zealand
Phone 9621 0
+64 7 8398899 (Ext. 8279)
Fax 9621 0
+64 7 8398899
Email 9621 0
CAMPBELI@waikatodhb.govt.nz
Contact person for scientific queries
Name 549 0
Xanthi Coskinas (Trial Co-ordinator)
Address 549 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 549 0
Australia
Phone 549 0
+61 2 95625049
Fax 549 0
+61 2 95625094
Email 549 0
xanthi.coskinas@ctc.usyd.edu.au