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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study

Important dates

Study start: 2017
Primary completion: 2027
Study completion: 2027
First posted: Aug 21, 2017
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting