Targeted Axillary Dissection for Early-stage Breast Cancer
Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla
This study tests a new surgery method for early-stage breast cancer to see if using a special seed to find and remove positive lymph nodes works better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jewish General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT04671511 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Targeted Axillary Dissection (TAD) in patients with early-stage breast cancer who have 1-2 positive lymph nodes identified through imaging. Participants will undergo a procedure where a radioactive seed is placed in the positive node before surgery, allowing for precise localization and removal during the operation. The study aims to assess the technical success and accuracy of this method compared to traditional approaches, with a focus on improving staging and treatment outcomes for patients with clinically negative axillae. Data will be collected on imaging, node characteristics, and pathology to better understand the benefits of this technique.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with T1-2 invasive breast cancer and clinically negative axillae but with 1-2 suspicious lymph nodes on ultrasound.
Not a fit: Patients with previous axillary surgery, distant metastases, or those who have received neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging and potentially less invasive treatment options for patients with early-stage breast cancer.
How similar studies have performed: While similar approaches have been discussed in expert consensus, this study aims to provide empirical evidence, making it a novel investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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.
Where this trial is running
Montreal, Quebec and 2 other locations
- Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada (Recruiting)
- Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Léamarie Meloche-Dumas, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Jean-François Boileau, MD,MSc,FRCSC
- Email: jean-francois.boileau@mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.