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Procedure
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
TADEN Trial Summary
This trial is testing a new method for axillary staging in breast cancer patients with 1-2 positive sentinel nodes. The new method uses radioactive seed localization (RSL) to guide removal of the biopsy-proven node (TAD). The study will compare the technical success rate and accuracy of SNB+RSL to standard SNB.
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.Check my eligibility
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.See study design
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.
TADEN Trial 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.
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My underarm lymph nodes tested positive for cancer.
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I can perform all my self-care and am up more than 50% of my waking hours.
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I have stage T1 or T2 breast cancer, regardless of hormone receptor status.
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I am 18 years old or older.
TADEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
Secondary outcome measures
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 moreTADEN 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
Find a Location
Who is running the clinical trial?
Jewish General HospitalLead Sponsor
137 Previous Clinical Trials
271,946 Total Patients Enrolled
Quebec Breast Cancer FoundationOTHER
6 Previous Clinical Trials
794 Total Patients Enrolled
Jean-François Boileau, MD,MSc,FRCSCStudy ChairJewish General Hospital
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in the trial overall?
"Correct. Per the information available on clinicaltrials.gov, recruitment is in progress for this trial which was first posted on March 30th 2021 and last amended May 19th 2021. The goal is to bring 98 patients into the study at 2 sites."
Answered by AI
Are there any current openings to join this research project?
"According to the clinicaltrials.gov database, this medical research project is currently seeking participants. It was first announced on March 30th 2021 and has undergone a recent revision of May 19th this year."
Answered by AI
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