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

• Register: ANZCTR
• Last refreshed on: 9 October 2023
• Main ID: ACTRN12605000409673
• Date of registration: 15/09/2005
• Prospective Registration: Yes
• Primary sponsor: National Health & Medical Research Council (NHMRC)
• 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
• Date of first enrolment: 18/07/2006
• Target sample size: 1012
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12605000409673.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, Hong Kong, New Zealand

Contacts

• Name: Ms SNAC2 Trial Operations Coordinator

• Name: A/Prof Dr Ian Campbell (Study Chair)

Key inclusion & exclusion criteria

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.
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.

Age minimum: Not stated
Age maximum: Not stated
Gender: Females

Health Condition(s) or Problem(s) studied

Cancer - Breast

Operable early breast cancer;
Operable early breast cancer

Intervention(s)

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.

Primary Outcome(s)

Ipsilateral Axillary Recurrence.[ Assessed at 1 month post definitive axillary surgery, 6 months after randomisaton and yearly for 10 years after randomisation.]

Secondary Outcome(s)

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[ Times to events will all be taken from the date of randomisation.]

Loco-regional recurrence includes recurrence in the ipsilateral axilla, breast or chest wall (each recorded separately for secondary analyses).[ Patient status will be measured at 6 months after randomisation and yearly for 10 years after randomisation.]

Distant recurrence includes development of metastatic breast cancer beyond the ipsilateral axilla, breast or chest wall.[ 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.]

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.[ 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.]

SNB negativity rate –which is the proportion of women with no cancer detected in their sentinel nodes.[ 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 ID(s)

Ni known.

Source(s) of Monetary Support

New Zealand Cancer Society

National Health and Medical Research Council

Multi-state Cancer Council funding

Ethics review

Status: Approved
Approval date: 11/11/2005
Contact:

Results

• Results available: Yes
• Date Posted: 28/09/2023
• Date Completed: 31/07/2023