RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.
PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
Participants must be ≥ 18 years old.
Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen/progesterone/human epidermal growth factor receptor 2 (HER2) receptor status.
Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.
Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.
Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
Participants with distant metastases.
Participants that have had previous radiotherapy to the axillary nodes.
Participants who received neoadjuvant therapy.
Single group
Targeted Axillary Dissection
Procedure/SurgerySentinel Node Biopsy (SNB; using Tc99 +/- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)
Ultrasound of the axilla
Diagnostic testProspectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
Recommended completion node dissection rate (CND) = false negative rate (FNR) + technical failure rate (TFR). TAD CND (TAD FNR + TAD TFR) vs. SNB CND (SNB FNR + SNB TFR)
Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)
Evaluate if the addition of SNB to RSL improves the ability to identify patients with 3+ positive nodes that do not otherwise meet the ACOSOG Z0011 criteria and require further regional axillary therapy
False negative rate (FNR) of Targeted Axillary Dissection (TAD)
Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)
Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)
Percentage of patients with unsuccessful removal of at least one node using this method, including the clipped node
False negative rate (FNR) of Radioactive Seed Localisation (RSL)
Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)
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Jewish General Hospital
Lead sponsor
Quebec Breast Cancer Foundation
Collaborator
