About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Targeted Axillary Dissection
- Ultrasound of the axilla
Treatment groups
Sponsors and collaborators
Jewish General Hospital
Lead sponsor
Quebec Breast Cancer Foundation
Collaborator