Titre Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla
Protocole ID TADEN
ClinicalTrials.gov ID NCT04671511
Type(s) de cancer Sein
Phase Autres
Type étude Clinique
Institution CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
   PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
      5415 boul. de l'Assomption, Montréal, QC, H1T2M4
Ville Montréal
Investigateur(trice) principal(e) Dr Lucas Sideris
Coordonnateur(trice) Audrey Lamoureux
 514-252-3400 poste 6258
Statut Actif en recrutement
Critètes d'éligibilité
  • 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.
Critètes d'exclusion
  • 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.