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

NCT01821768 | Terminated DMC

• 1 other identifier: 201209143
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disease free survival Arm 1 versus Arm 2.

  At least 5 years form date of surgery to date of any disease recurrence.

• Overall survival Arm 1 versus Arm 2

  5 years from date of surgery

Study Arms (2)

Arm 1: No sentinal lymph node biopsy

NO INTERVENTION

Patients will receive no additional axillary surgery which is experimental.

Arm 2: Sentinel lymph node biopsy

ACTIVE COMPARATOR

Patients will receive standard of care sentinel lymph node biopsy

Procedure: Sentinel Lymph Node Biopsy

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

Arm 2: Sentinel lymph node biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Amy Cyr, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 1, 2013
• Study Start: April 4, 2013
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)