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

NCT ID: NCT03255577

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2026-08-30

Brief Summary

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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

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Conditions

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Breast Cancer Locally Advanced Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a prospective single-arm study design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sentinel Lymph Node Biopsy (SLNB)

Intervention Type PROCEDURE

Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.

Interventions

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Sentinel Lymph Node Biopsy (SLNB)

Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Barrio, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States

Site Status RECRUITING

Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent only and Follow Up)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Consent only and Follow Up)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Barrio, MD

Role: CONTACT

646-888-5117

Monica Morrow, MD

Role: CONTACT

646-888-5350

Facility Contacts

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Starr Mautner, MD

Role: primary

786-596-2000

Andrea Barrio, MD

Role: primary

646-888-5117

Andrea Barrio, MD

Role: primary

646-888-5117

Andrea Barrio, MD

Role: primary

646-888-5117

Andrea Barrio, MD

Role: primary

646-888-5117

Andrea Barrio, MD

Role: primary

646-888-5117

Andrea Barrio, MD

Role: primary

646-888-5117

Monica Morrow, MD

Role: backup

646-888-5350

Andrea Barrio, MD

Role: primary

646-888-5117

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-384

Identifier Type: -

Identifier Source: org_study_id

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