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Targeted Axillary Dissection for Early-stage Breast Cancer (TADEN Trial)
N/A
Recruiting
Led By Léamarie Meloche-Dumas, MD
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Participants who received neoadjuvant therapy
Participants who are unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new method to find and remove specific lymph nodes in breast cancer patients. It targets patients with limited suspicious lymph nodes but no noticeable lumps. The technique helps doctors accurately locate and remove the right lymph nodes during surgery.
Who is the study for?
This trial is for adults over 18 with early-stage node-positive breast cancer, specifically T1 or T2 invasive ductal or lobular carcinoma. They must have no more than two suspicious lymph nodes on ultrasound and a good performance status (ECOG < 2). Patients with allergies to certain dyes, previous axillary surgery, distant metastases, prior neoadjuvant therapy or radiotherapy to the axilla are excluded.
What is being tested?
The study tests Targeted Axillary Dissection (TAD) in patients who have limited nodal disease visible on imaging but clinically non-palpable nodes. It involves clipping and removing biopsy-proven positive nodes using radioactive seed localization along with sentinel node biopsy.
What are the potential side effects?
Potential side effects may include discomfort from the procedure, risk of infection at the incision site, possible allergic reactions to materials used during dissection or imaging, and temporary swelling or bruising.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has not visibly spread to more than two lymph nodes.
Select...
My underarm lymph nodes tested positive for cancer.
Select...
I can perform all my self-care and am up more than 50% of my waking hours.
Select...
I have stage T1 or T2 breast cancer, regardless of hormone receptor status.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received treatment before surgery to shrink my tumor.
Select...
I am unable to understand or sign the consent form.
Select...
I have had surgery on the same side's armpit area before.
Select...
My cancer has spread to distant parts of my body.
Select...
I have had radiation therapy to the lymph nodes under my arm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
Secondary study objectives
False negative rate (FNR) of Radioactive Seed Localisation (RSL)
False negative rate (FNR) of Sentinel Node Biopsy (SNB)
False negative rate (FNR) of Targeted Axillary Dissection (TAD)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Targeted Axillary DissectionExperimental Treatment2 Interventions
Ultrasound of the axilla preoperative. Clipped biopsy proven positive node. I125 radioactive seed before surgery. Sentinel node biopsy using Tc99 +/- blue dye. Targeted Axillary Node Dissection performed at surgery
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The combination of Sentinel Node Biopsy (SNB) and Radioactive Seed Localization (RSL) in Targeted Axillary Dissection (TAD) aims to accurately stage and treat axillary lymph nodes in breast cancer patients with limited nodal disease. SNB identifies the first lymph node(s) likely to be affected by metastasis, while RSL uses a radioactive seed to precisely locate and remove the biopsy-proven positive node.
This targeted approach minimizes surgical morbidity and improves staging accuracy. For metastatic breast cancer, targeted therapies often involve monoclonal antibodies or small molecules that inhibit specific pathways critical for tumor growth and spread, such as HER2 inhibitors or angiogenesis inhibitors.
These treatments are crucial as they offer more personalized and effective options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.
Deciphering and Targeting Oncogenic Mutations and Pathways in Breast Cancer.Antiangiogenesis therapy for breast cancer: an update and perspectives from clinical trials.The next generation of biologic agents: therapeutic role in relation to existing therapies in metastatic breast cancer.
Deciphering and Targeting Oncogenic Mutations and Pathways in Breast Cancer.Antiangiogenesis therapy for breast cancer: an update and perspectives from clinical trials.The next generation of biologic agents: therapeutic role in relation to existing therapies in metastatic breast cancer.
Find a Location
Who is running the clinical trial?
Jewish General HospitalLead Sponsor
142 Previous Clinical Trials
279,553 Total Patients Enrolled
1 Trials studying Sentinel Lymph Node
100 Patients Enrolled for Sentinel Lymph Node
Quebec Breast Cancer FoundationOTHER
6 Previous Clinical Trials
794 Total Patients Enrolled
Jean-François Boileau, MD,MSc,FRCSCStudy ChairJewish General Hospital
Léamarie Meloche-Dumas, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Erica Patocskai, MDStudy DirectorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has not visibly spread to more than two lymph nodes.My underarm lymph nodes tested positive for cancer.I have received treatment before surgery to shrink my tumor.I can perform all my self-care and am up more than 50% of my waking hours.I have stage T1 or T2 breast cancer, regardless of hormone receptor status.I am 18 years old or older.You are allergic to certain dyes that may be used in the injection.I am unable to understand or sign the consent form.I have had surgery on the same side's armpit area before.My cancer has spread to distant parts of my body.I have had radiation therapy to the lymph nodes under my arm.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Axillary Dissection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.