Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer

Launched by JEWISH GENERAL HOSPITAL · Dec 12, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach for women with early-stage breast cancer who have a few positive lymph nodes. Specifically, it is studying the effectiveness of a method called Targeted Axillary Dissection (TAD), which combines a special type of biopsy known as sentinel node biopsy (SNB) with a technique called radioactive seed localization (RSL). The goal is to see how well this method works in accurately removing and checking the lymph nodes that might be affected by cancer when only a small number are involved and the rest of the area seems normal.

To participate in this trial, women must be at least 18 years old and have certain types of breast cancer with a specific stage and nodal status. They should have one or two suspicious lymph nodes found on imaging but should not have had prior surgery in that area. Participants can expect to undergo the targeted procedure to see if it helps in managing their cancer better. The trial is currently recruiting, and it’s important for potential participants to understand the criteria for inclusion and to be willing to provide informed consent before joining.

Gender

FEMALE

Eligibility 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.