Status:
RECRUITING
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Quebec Breast Cancer Foundation
Conditions:
Breast Cancer Female
Early-stage Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 Oncol...
Detailed Description
This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven positive node (by core bi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04671511
Start Date
March 30 2021
End Date
July 1 2026
Last Update
February 20 2025
Active Locations (3)
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1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T2M4
2
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2