Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy

Study Overview
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Brief Summary
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This randomized clinical trial studies two different tests that are currently being used to detect the spread of breast cancer to the lymph nodes under the arm in candidates for breast conservation therapy. The two tests are sentinel lymph node biopsy (SLNB) and axillary ultrasound. The current standard of care is sentinel lymph node biopsy, which is a surgical procedure. Axillary ultrasound (AUS) may be just as good as SLNB for detecting the spread of cancer but without the surgical risks.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Sentinel Lymph Node Biopsy


Participation Criteria
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Eligibility Criteria
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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). For patients who will receive neoadjuvant systemic therapy, pre-treatment clinical stage should be used. 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 mm. Patient must have a tissue diagnosis of invasive breast carcinoma Patient must have Eastern Cooperative Oncology Group (ECOG) status </= 2, as 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 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, or the patient's legally acceptable representative, must provide a signed and dated written informed consent prior to registration and any study-related procedures. 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 disease. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: No sentinal lymph node biopsy<br>Patients will receive no additional axillary surgery which is experimental. | |
| Active Comparator: Arm 2: Sentinel lymph node biopsy<br>Patients will receive standard of care sentinel lymph node biopsy | Procedure: Sentinel Lymph Node Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional (axillary) recurrence | The distributions of the primary endpoints and complications across two arms will be summarized using contingency tables and compared by 2-sample Chi-square test or Fisher's exact test. | 5 years from date of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival Arm 1 versus Arm 2. | Defined as the interval between the date of registration to the date of first disease event. Kaplan-Meier product limit estimator will be used. The differences in OS and DFS between treatment arms will be compared using log-rank test. | At least 5 years form date of surgery to date of any disease recurrence. | 
| Overall survival Arm 1 versus Arm 2 | Defined as the interval between the date of initial diagnosis until the date of death. Kaplan-Meier product limit estimator will be used. The differences in OS and DFS between treatment arms will be compared using log-rank test. | 5 years from date of surgery |