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Closed (no longer recruiting)Last updated: 20 December 2023

SNAC2: This phase III trial is assessing the effect of sentinal node based management on risk of recurrence in patients with early stage breast cancerA 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.

Clinical summary

Summary

SNAC-2 is a national trial comparing two operations for detecting cancer cells in the lymph nodes of women with early breast cancer. The two operations are: 1) axillary clearance and 2) sentinel node biopsy. The standard of treatment for early stage breast cancer is axillary clearance which is the removal of most of the lymph nodes under the armpit (axilla). The new treatment is sentinel node biopsy where only the first few lymph nodes most closely related to the cancer are removed. We know that removing only the sentinel nodes may cause fewer side effects than doing an axillary clearance. The goal of SNAC2 is to establish the risk of local recurrence and long term safety of sentinel node biopsy, especially for women with larger or multiple tumours.

Conditions

This trial is treating patients with breast cancer.

Cancer

Breast Cancers Breast

Age

People18 - 75

Phase

III

Trial Acronym

SNAC2

More information

Trial Identifiers

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Trial sponsor

National Health & Medical Research Council (NHMRC)

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.

Eligibility

Inclusion

  • 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

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.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
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