Suspended
A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound
What is being tested
Sentinel Lymph Node Biopsy
Procedure
Who is being recruted
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Diagnostic Study
Interventional
Study Start: April 2013
Summary
Principal SponsorWashington University School of Medicine
Last updated: March 5, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: April 4, 2013
Actual date on which the first participant was enrolled.In this prospective randomized non-inferiority study we aim to determine the utility of axillary ultrasound (AUS) as a pre-operative staging modality for patients with clinically node-negative invasive breast cancer with the hope that it will be a minimally invasive replacement for SLNB.
Principal SponsorWashington University School of Medicine
Last updated: March 5, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
69 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms
Criteria
11 inclusion criteria required to participate
A patient with a history of previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met (1) The patient has undergone potentially curative therapy for all prior malignancies; (2) There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone); and (3) The patient is deemed by their treating physician to be at low risks for recurrence from prior malignancies
Patient must be a candidate for sentinel lymph node biopsy (SLNB)
Patient must be at least 18 years of age
Patient must be available for follow-up
Show More Criteria
4 exclusion criteria prevent from participating
Patient has concurrent invasive bilateral breast malignancies or multicentric disease
Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph nodes(s), treatment of hidradenitis
Patient in lactating (breast-feeding) or pregnant
Patient is considered poor candidate surgical candidate due to non-malignant systemic disease
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionPatients will receive no additional axillary surgery which is experimental.
Group II
Active ComparatorPatients will receive standard of care sentinel lymph node biopsy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Washington University School of Medicine
St Louis, United StatesOpen Washington University School of Medicine in Google MapsSuspendedOne Study Center