Targeted Axillary Dissection for Early-stage Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Targeted Axillary Dissection (TAD) in patients with early-stage breast cancer who have 1-2 positive lymph nodes identified through imaging. Participants will undergo a procedure where a radioactive seed is placed in the positive node before surgery, allowing for precise localization and removal during the operation. The study aims to assess the technical success and accuracy of this method compared to traditional approaches, with a focus on improving staging and treatment outcomes for patients with clinically negative axillae. Data will be collected on imaging, node characteristics, and pathology to better understand the benefits of this technique.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Maisonneuve-Rosemont
  Montreal, Quebec, Canada Recruiting
• Centre hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting
• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Léamarie Meloche-Dumas, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Jean-François Boileau, MD,MSc,FRCSC
• Email: jean-francois.boileau@mcgill.ca
• Phone: 514-340-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.