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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
000484
ACTR Number:
ACTRN12605000409673
Trial Status:
Registered
Date Submitted:
9/09/2005
Date Registered:
15/09/2005
Page 1
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
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Reason:
ANZCTR registration 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
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Secondary ID:
UTN:
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Trial acronym:
SNAC2
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Page 2
Health condition(s) or problem(s) studied:
Operable early breast cancer
Condition category:
Condition code:
Cancer
Breast
Page 3
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.
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Reason:
Intervention code:
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.
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Reason:
Control group:
Active
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Reason:
Page 4
Primary outcome:
To determine if sentinel node based management increases the risk of loco-regional recurrence compared with axillary clearance in any subgroup of women
Timepoint:
Assessed at 1 month post definitive axillary surgery, 6 months after randomisaton and yearly for 10 years after randomisation.
Secondary outcome 1:
If sentinel node based management affects overall survival or distant disease free survival.
Timepoint:
Patient status will be measured at 6 months after randomisation and yearly for 10 years after randomisation.
Secondary outcome 2:
The outcomes of SNB vs AC in the subgroup of women with negative SNB.
Timepoint:
Patient status will be measured at 6 months after randomisation and yearly for 10 years after randomisation.
Secondary outcome 3:
SNB negative rates for those randomised to SNB vs those randomised to AC.
Timepoint:
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:
Variations among centres in the diagnostic accuracy of SNB among those randomised to AC who have a negative SNB:
Timepoint:
Variations among centres will be assessed following sentinel node biopsy and axillary clearance where the sentinel node biopsy result is negative.
Secondary outcome 5:
The clinical and pathological features that may predict risk of a false negative sentinel node:
Timepoint:
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.
Page 5
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.
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Minimum Age:
Not stated
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Maximum Age:
Not stated
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Gender:
Females
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Healthy volunteers?
No
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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.
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Central randomisation
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Computer generated -Minimisation, stratification
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Masking / blinding:
Open (masking not used)
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Safety/efficacy
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Page 7
Phase
Phase 3
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Reason:
Anticipated or actual date of first participant enrolement:
18/07/2006
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Target sample size:
1012
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Recruitment status:
Open to recruitment
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Page 8
Funding source 1:
Government funding body e.g. Australian Research Council
Name:
National Health and Medical Research Council
Address:
Canberra
Country:
Australia
Funding source 2:
Charities/Societies/Foundations
Name:
New Zealand Cancer Society
Address:
Wakefield House 90 The Terrace PO Box 10847 Wellington New Zealand
Country:
New Zealand
Funding source 3:
Government funding body e.g. Australian Research Council
Name:
Multi-state Cancer Council funding
Address:
Queensland, South Australia, New South Wales, Victoria
Country:
Australia
Primary sponsor:
Government funding body e.g. Department of Health
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Reason:
Name:
National Health & Medical Research Council (NHMRC)
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Address:
88 Mallett St Campderdown NSW 2050
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Country:
Australia
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Secondary sponsor:
None
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Address:
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Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Reason:
Ethics Committee:
Countries of recruitment:
Australia
Postcode:
Outside Australia
New Zealand
Brief summary:
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Trial website:
http://www.ctc.usyd.edu.au/trials/cancer/breast.htm
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Dr Ian Campbell (Study Chair)
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Reason:
Address:
Department of Surgery Waikato Hospital Private Bag 3200 Hamilton
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Country:
New Zealand
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Tel:
+64 7 8398899 (Ext. 8279)
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Fax:
+64 7 8398899
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Email:
CAMPBELI@waikatodhb.govt.nz
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Contact person for scientific queries
Name:
Xanthi Coskinas (Trial Co-ordinator)
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Address:
National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
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Country:
Australia
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Tel:
+61 2 95625049
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Fax:
+61 2 95625094
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Email:
xanthi.coskinas@ctc.usyd.edu.au
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