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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000409673

Acronym

SNAC2

Enrollment

326

Registered

2005-09-15

Start date

2006-07-18

Completion date

2015-01-05

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Sentinel Node versus Axillary Clearance (SNAC) trial was the first, large, Australasian prospective assessment of the risk of lymphoedema after surgery for early breast cancer. The trial compared sentinel node biopsy of selected lymph nodes with clearance of axillary nodes in women with tumours smaller than 3 cm. Short-term results showed that arm swelling was less in the group having only sentinel node biopsy. Both treatment groups had moderate limitations in arm movement over the first 6 months, which then recovered to near normal levels. The results showed that for women with small tumours, sentinel node biopsy was a viable alternative to axillary clearance. The patients are being followed up so that long-term effects can be measured. Outcomes at 3 years will shortly be published. In SNAC 2, the investigators are recruiting women with large or multiple tumours in a more extensive trial with similar questions, which will allow any differences in subgroups of women to be analysed.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results