Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000409673
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
28/09/2023
Date data sharing statement initially provided
28/09/2023
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
Secondary ID [1] 310703 0
Ni known.
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
Ipsilateral Axillary Recurrence.
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
Loco-regional recurrence includes recurrence in the ipsilateral axilla, breast or chest wall (each recorded separately for secondary analyses).
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
Distant recurrence includes development of metastatic breast cancer beyond the ipsilateral axilla, breast or chest wall.
Timepoint [2] 1427 0
Any breast cancer recurrence will include all loco-regional and distant recurrences as events, but will exclude the development of contralateral primaries and contralateral loco-regional recurrences.
Secondary outcome [3] 1428 0
Death from any cause will include all deaths as events. Death due to breast cancer will include all deaths that are attributed to breast cancer, or that occur after the development of distant recurrence, but will censor deaths due to other causes
Timepoint [3] 1428 0
Times to events will all be taken from the date of randomisation.
Secondary outcome [4] 1429 0
SNB negativity rate –which is the proportion of women with no cancer detected in their sentinel nodes.
Timepoint [4] 1429 0
False negative rate of sentinel node based management: SNB false negative rates: the proportion of women with cancer in their ACN who do not have cancer in their SN or NSN.
Secondary outcome [5] 1430 0
False negative rate of sentinel node biopsy: proportion of women with cancer in their ACN or NSN, who do not have cancer in their SN.
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
Sex
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2006
Actual
18/07/2006
Date of last participant enrolment
Anticipated
Actual
5/01/2015
Date of last data collection
Anticipated
31/12/2020
Actual
31/07/2023
Sample size
Target
1012
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 194 0
New Zealand
State/province [1] 194 0
Country [2] 25816 0
Hong Kong
State/province [2] 25816 0
Hong Kong Island

Funding & Sponsors
Funding source category [1] 648 0
Government body
Name [1] 648 0
National Health and Medical Research Council
Country [1] 648 0
Australia
Funding source category [2] 2863 0
Charities/Societies/Foundations
Name [2] 2863 0
New Zealand Cancer Society
Country [2] 2863 0
New Zealand
Funding source category [3] 2884 0
Government body
Name [3] 2884 0
Multi-state Cancer Council funding
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
Ethics committee name [1] 297279 0
University of Sydney HREC
Ethics committee address [1] 297279 0
Ethics committee country [1] 297279 0
Australia
Date submitted for ethics approval [1] 297279 0
27/10/2005
Approval date [1] 297279 0
11/11/2005
Ethics approval number [1] 297279 0
11-2005/5/8705

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

Contacts
Principal investigator
Name 35369 0
A/Prof Ian Campbell
Address 35369 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 35369 0
Australia
Phone 35369 0
+61 2 9562 5000
Fax 35369 0
Email 35369 0
[email protected]
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
[email protected]
Contact person for scientific queries
Name 549 0
SNAC2 Trial Operations Coordinator
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 95625000
Fax 549 0
+61 2 95625094
Email 549 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment and piloting of a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 breast cancer trial.2015https://dx.doi.org/10.1177/1740774515586404
N.B. These documents automatically identified may not have been verified by the study sponsor.