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

Not Applicable

Recruiting

• Conditions: Locally Advanced Breast Cancer; Breast Cancer
• Interventions: Procedure: Sentinel Lymph Node Biopsy (SLNB)

• Registration Number: NCT03255577
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-17
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Biopsy (SLNB)	Sentinel Lymph Node Biopsy (SLNB)	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

Primary Outcome Measures

Name	Time	Method
The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer	3 years

Trial Locations

Locations (8)

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only and Follow Up); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up); 🇺🇸 Basking Ridge, New Jersey, United States

BAPTIST ALLIANCE - MCI (Data Collection Only); 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Nassau (Consent only and Follow Up); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States