| Title |
Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla |
| Protocole ID |
TADEN |
| ClinicalTrials.gov ID |
NCT04671511 |
| Cancer Type(s) |
Breast |
| Phase |
Other |
| Stage |
|
| Study Type |
Clinical |
| Drug |
|
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
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| Principal Investigator |
Dr. Erika Patocskai
|
| Coordinator |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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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Groupe d'étude en oncologie du Québec