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

Breast Cancer Female | Lymph Node Metastases | Sentinel Lymph Node | Early-stage Breast Cancer | Axillary Metastases

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.

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Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 and up

Participation 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.

Study Location

Hôpital Maisonneuve-Rosemont
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Lucas Sidéris, MD

[email protected]
514-252-0606
Centre hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Léamarie Meloche-Dumas, MD

[email protected]
438-826-7489
Backup Contact

Erica Patocskai, MD

[email protected]
514 890-8000
Jewish General Hospital
Jewish General Hospital
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Jean-François Boileau, MD,MSc,FRCSC

[email protected]
514-340-8222
Study Sponsored By
Jewish General Hospital
Participants Required
More Information
Study ID: NCT04671511