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NCT03255577 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03255577
Other study ID # 17-384
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2017
Est. completion date August 30, 2024

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Andrea Barrio, MD
Phone 646-888-5117
Email barrioa@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date August 30, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
United States Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States BAPTIST ALLIANCE - MCI (Data Collection Only) Miami Florida
United States 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 Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only and Follow Up) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer 3 years
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