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A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T-1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound

18 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T-1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound

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.

Inclusion Criteria:

- Patient must be female.

- Patient must be at least 18 years of age.

- Patient's clinical stage must be documented as tumor size less than 5 cm, with no
palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0)

- Patient must have a negative (normal) axillary ultrasound performed at Siteman Cancer
Center. Lymph nodes will be evaluated based on morphologic features. AUS wil be
considered positive (abnormal)if lymph nodes are noted to be completely hypoechoic
(absent hilum) or have focal hypoechoic cortical thickening/lobulation greater than 4

- Patient must have a tissue diagnosis of invasive breast carcinoma

- Patient must have Eastern Cooperative Oncology Group (ECOG) status documented in patient's medical record.

- Patient must be available for follow-up.

- 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 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 riks for recurrence from prior malignancies.

- Patient, or the patient's legally acceptable representative, must provide a signed
and date written informed consent prior to registration and any study-related

- Patient must provide written authorization to allow the use and disclosure of their
protected health information. NOTE: This may be obtained in either the
study-specific informed consent or in a separate authorization form and must be
obtained from the patient prior to study registration.

- Patient must be a candidate for sentinel lymph node biopsy (SLNB).

- Exclusion Criteria:

- Patient in lactating (breast-feeding) or pregnant.

- Patient has concurrent invasive bilateral breast malignancies or multicentric

- Patient has had previous ipsilateral axillary surgery such as excisional biopsy of
lymph nodes(s), treatment of hidradenitis.

- Patient is considered poor candidate surgical candidate due to non-malignant
systemic disease.

- Patient has undergone or plans to undergo neoadjuvant chemotherapy of endocrine

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Regional (axillary) recurrence

Outcome Time Frame:

5 years from date of surgery

Safety Issue:


Principal Investigator

Amy Cyr, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

July 2020

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110