Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
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.
This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically
 negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven
 positive node (by core biopsy of fine needle aspiration) will have a radioactive seed (I125)
 placed in their clipped node before surgery. At the time of surgery, patients that are
 scheduled for breast conserving surgery or mastectomy will have sentinel node biopsy (SNB)
 using radioactive dye (Tc99) +/- blue dye as well as retrieval of the clipped node using
 radioactive seed localisation (RSL). Removal of the I125 radioactive seed in the clipped node
 will be performed before the Tc99 counts are performed to prevent "shine through" and biased
 measurements. Imaging of the surgical specimen will confirm retrieval of the clipped node.
 Prospectively recorded information on pre-operative axillary imaging, characteristics of the
 retrieved nodes in the operating room and detailed pathological analysis of each
 corresponding node will be performed. Completion node dissection (CND) is not mandatory in
 this study but recommended if the clipped positive node is not retrieved, if 4 nodes or more
 are positive or if 3 nodes are positive in the absence of axillary radiation. The benefits of
 adding RSL to SNB and the benefits of adding SNB to RSL staging of the axilla will be
 evaluated in this study and will help to better define the value of using TAD in this patient
 population.
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.