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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: 000448
ACTR Number: ACTRN12605000357651
Trial Status: Registered
Date Submitted: 7/09/2005
Date Registered: 9/09/2005

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Public title: SNAC Trial
ANZCTR registration 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.
Secondary ID: 
UTN:
Trial acronym: SNAC Trial

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

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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:Treatment: surgery 
Comparator / control treatment:
Control group: Active

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

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Key inclusion criteria: Histologically or cytologically confirmed invasive breast cancer.
Minimum Age: Not stated
Maximum Age: Not stated
Gender: Females
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Central randomisation
Describe the 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)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 1/05/2001
Target sample size: 1000
Recruitment status: Closed: follow-up continuing

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Funding source: 
Name: 
Address: 
Country: 
Primary sponsor: Government funding body e.g. Department of Health
Name: NHMRC
Address:
Country: Australia
Secondary sponsor:Charities/Societies/Foundations 
Name:NBCF 
Address: 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Prince Alfred Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Westmead Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:Concord Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 4:Coffs Harbour Base Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 5:Nepean Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:St Vincent's Mater Hospital, Sydney 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 7:Strathfield Breast Centre 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 8:Baringa Private Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 9:Royal Melbourne Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 10:St Vincent's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 11:Geelong Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 12:Royal Women's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 13:Princess Alexandra Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 14:Mater Private Hospital, Brisbane 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 15:Nambour General Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 16:Wesley Medical Centre 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 17:Mater Adult Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 18:Royal Adelaide Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 19:St Andrew's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 20:Queen Elizabeth Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 21:Western Breast Clinic 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 22:Sir Charles Gairdner Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 23:Middlemore Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 24:North Shore Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 25:Waikato Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 26:Palmerston North Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 27:Auckland Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 28:St John of God Hospital, Murdoch 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 29:St Vincent's Private Hospital 
Address:Lismore NSW 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 30:Lismore Base Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 31:Gold Coast Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief summary: There are 32 active sites.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Associate Professor Grantley Gill (Study Chair)
Address: Breast Endocrine Surgical Oncology Unit The University of Adelaide North Terrace Campus Level 6 East Wing Link Adelaide SA 5000
Country: Australia
Tel: +61 8 82224154
Fax: +61 8 82326761
Email: grantley.gill@adelaide.edu.au

Contact person for scientific queries
Name: Xanthi Coskinas
Address: National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked bag 77 Camperdown NSW 1450
Country: Australia
Tel: +61 2 95625049
Fax: +61 2 95625094
Email: xanthi.coskinas@ctc.usyd.edu.au

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