Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer; Locally Advanced Breast Cancer

Treatments: Procedure: Sentinel Lymph Node Biopsy (SLNB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03255577

17-384

Details and patient eligibility

About

This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients over 18 years of age with biopsy-proven breast cancer
• Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
• Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies
• Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam

Exclusion criteria

• Patients with a prior history of ipsilateral breast cancer
• Pregnant patients
• Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
• Patients not consenting to ALND

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Sentinel Lymph Node Biopsy (SLNB)

Experimental group

Description:

The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed

Treatment:

Procedure: Sentinel Lymph Node Biopsy (SLNB)