Actively Recruiting
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
Led by Jewish General Hospital · Updated on 2025-02-20
98
Participants Needed
3
Research Sites
274 weeks
Total Duration
On this page
Sponsors
J
Jewish General Hospital
Lead Sponsor
Q
Quebec Breast Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
CONDITIONS
Official Title
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants with clinical T1 or T2 invasive ductal or lobular breast cancer.
- Participants must have clinically negative axilla on palpation with up to two suspicious lymph nodes on ultrasound.
- Biopsy-proven positive axillary disease by core needle biopsy or fine-needle aspiration.
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
- Participants must understand and sign the approved consent form.
You will not qualify if you...
- Previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
- Presence of distant metastases.
- Previous radiotherapy to axillary nodes.
- Prior neoadjuvant therapy.
- Allergy or hypersensitivity to blue dyes or radiocolloid dye if blue dye injection is planned.
- Inability to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T2M4
Actively Recruiting
2
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
J
Jean-François Boileau, MD,MSc,FRCSC
CONTACT
L
Léamarie Meloche-Dumas, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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