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

RecruitingNAAges 18 Years - anyFemaleJewish General Hospital
NCT04671511 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2. * Participants must understand, accept, and have signed the approved consent form. Exclusion Criteria: * 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. * If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye. * Participants who are unable to provide informed consent.
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What it tests

  • Targeted Axillary Dissection
  • Ultrasound of the axilla
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Where

3 sites
Hôpital Maisonneuve-Rosemont
Montreal, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Canada
Jewish General Hospital
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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