| TITRE |
Biopsie des ganglions sentinelles et évidement ganglionnaire axillaire ciblé chez les patientes atteintes d’un cancer du sein avec atteinte ganglionnaire et avec résultats cliniques négatifs au niveau de l’aisselle |
| PROTOCOLE ID |
TADEN |
| CLINICAL TRIAL.gov ID |
NCT04671511 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Erika Patocskai
|
| COORDONATEUR(RICE) |
Ana Lydia Tkalec
grcs.chum@ssss.gouv.qc.ca
514-890-8000 poste 14186
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
