- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03255577
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer
December 18, 2023 updated by: Memorial Sloan Kettering Cancer Center
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Barrio, MD
- Phone Number: 646-888-5117
- Email: barrioa@mskcc.org
Study Contact Backup
- Name: Monica Morrow, MD
- Phone Number: 646-888-5350
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33143
- Recruiting
- BAPTIST ALLIANCE - MCI (Data Collection Only)
-
Contact:
- Starr Mautner, MD
- Phone Number: 786-596-2000
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Consent only and Follow Up)
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Monica Morrow, MD
- Phone Number: 646-888-5350
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
Principal Investigator:
- Andrea Barrio, MD
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Consent only and Follow Up)
-
Contact:
- Andrea Barrio, MD
- Phone Number: 646-888-5117
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Barrio, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2017
Primary Completion (Estimated)
June 15, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
August 18, 2017
First Submitted That Met QC Criteria
August 18, 2017
First Posted (Actual)
August 21, 2017
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-384
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Institute of Oncology, HungaryCompleted
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University Hospital OstravaSilesian Hospital in OpavaCompletedBreast CancerCzechia
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Shandong Cancer Hospital and InstituteCompleted
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-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IA2 Cervical Cancer AJCC v6 and v7 | Stage IB1 Cervical Cancer AJCC v6 and v7United States, Brazil, Colombia, Peru, Mexico, Argentina, Australia, Thailand
-
Shandong Cancer Hospital and InstituteHenan Cancer Hospital; The Affiliated Hospital of Qingdao UniversityUnknown
-
National Cancer Center, KoreaCompletedBreast CancerKorea, Republic of
-
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