NCT04671511 Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
| NCT ID | NCT04671511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jewish General Hospital |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2021-03-30 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2021-03-30 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Jean-François Boileau, MD,MSc,FRCSC
STUDY CHAIR
Jewish General Hospital
Frequently Asked Questions
Who can join the NCT04671511 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04671511 currently recruiting?
Yes, NCT04671511 is actively recruiting participants. Contact the research team at jean-francois.boileau@mcgill.ca for enrollment information.
Where is the NCT04671511 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT04671511 clinical trial?
NCT04671511 is sponsored by Jewish General Hospital. The principal investigator is Jean-François Boileau, MD,MSc,FRCSC at Jewish General Hospital. The trial plans to enroll 98 participants.
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