CompletedPhase 3ACTRN12605000409673

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


Sponsor

National Health & Medical Research Council (NHMRC)

Enrollment

1,012 participants

Start Date

Jul 18, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 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. It may be open to women who 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. Participation typically involves regular medical visits, tests, and following the study's treatment plan.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(2)

New Zealand

Hong Kong Island, Hong Kong

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ACTRN12605000409673