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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03255577

Collaborator

(none)

150

Enrollment

Locations

Arm

71.5

Anticipated Duration (Months)

18.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Locally Advanced Breast Cancer	Procedure: Sentinel Lymph Node Biopsy (SLNB)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This will be a prospective single-arm study design.This will be a prospective single-arm study design.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 17, 2017

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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	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.

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

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.

Outcome Measures

Primary Outcome Measures

The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BAPTIST ALLIANCE - MCI (Data Collection Only)	Miami	Florida	United States	33143
2	Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)	Basking Ridge	New Jersey	United States	07920
3	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Bergen (Consent only and Follow Up)	Montvale	New Jersey	United States	07645
5	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
6	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Memorial Sloan Kettering Nassau (Consent only and Follow Up)	Uniondale	New York	United States	11553

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Andrea Barrio, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT03255577

Other Study ID Numbers:

17-384

First Posted:

Aug 21, 2017

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Sentinel Lymph Node Biopsy

17-384

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Aug 10, 2022