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

Primary Purpose

Breast Cancer, Locally Advanced Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sentinel Lymph Node Biopsy (SLNB)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Sentinel Lymph Node Biopsy, 17-384

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • BAPTIST ALLIANCE - MCI (Data Collection Only)Recruiting
  • Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)Recruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering Bergen (Consent only and Follow Up)Recruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (Consent only and Follow Up)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentinel Lymph Node Biopsy (SLNB)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 18, 2017
Last Updated
May 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03255577
Brief Title
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer
Official Title
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Locally Advanced Breast Cancer
Keywords
Sentinel Lymph Node Biopsy, 17-384

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a prospective single-arm study design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel Lymph Node Biopsy (SLNB)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy (SLNB)
Intervention Description
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 Outcome Measure Information:
Title
The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
Time Frame
3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Barrio, MD
Phone
646-888-5117
Email
barrioa@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Morrow, MD
Phone
646-888-5350
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
BAPTIST ALLIANCE - MCI (Data Collection Only)
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Starr Mautner, MD
Phone
786-596-2000
Facility Name
Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
Facility Name
Memorial Sloan Kettering Bergen (Consent only and Follow Up)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117
First Name & Middle Initial & Last Name & Degree
Monica Morrow, MD
Phone
646-888-5350
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Facility Name
Memorial Sloan Kettering Nassau (Consent only and Follow Up)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Barrio, MD
Phone
646-888-5117

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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