RecruitingNot ApplicableNCT04671511

Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer

Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla

Sponsor

Jewish General Hospital

Enrollment

98 participants

Start Date

Mar 30, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female Sentinel Lymph Node Early Stage Breast Cancer Lymph Node Metastases Axillary Metastases

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a surgical technique called Targeted Axillary Dissection (TAD) for breast cancer patients who were found to have cancer in their lymph nodes before treatment. TAD aims to remove only the specific lymph nodes that were affected, rather than all lymph nodes in the armpit, potentially reducing side effects like arm swelling. **You may be eligible if you:** - Are 18 years of age or older - Have early-stage invasive breast cancer (T1 or T2) - Had up to two suspicious lymph nodes identified by ultrasound, confirmed to be cancerous by needle biopsy - Are in good health (ECOG performance status less than 2) **You may NOT be eligible if you:** - Have more than two suspicious lymph nodes on ultrasound - Have inflammatory breast cancer - Have had previous breast or axillary (armpit) surgery Talk to your doctor to see if this trial is right for you.

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

PROCEDURETargeted Axillary Dissection

Sentinel Node Biopsy (SNB; using Tc99 +/- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)

DIAGNOSTIC_TESTUltrasound of the axilla

Prospectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.