NCT03255577

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
4mo left

Started Aug 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2017Aug 2026

Study Start

First participant enrolled

August 17, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

8.8 years

First QC Date

August 18, 2017

Last Update Submit

March 3, 2026

Conditions

Breast CancerLocally Advanced Breast Cancer

Keywords

Sentinel Lymph Node Biopsy17-384

Outcome Measures

Primary Outcomes (1)

  • The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer

    3 years

Study Arms (1)

Sentinel Lymph Node Biopsy (SLNB)

EXPERIMENTAL

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

Procedure: Sentinel Lymph Node Biopsy (SLNB)

Interventions

Sentinel Lymph Node Biopsy (SLNB)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.

Sentinel Lymph Node Biopsy (SLNB)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, 33143, United States

Location

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

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only and Follow Up)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only and Follow Up)

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Andrea Barrio, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This will be a prospective single-arm study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 21, 2017

Study Start

August 17, 2017

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(8)