Trial record 1 of 1 for:    sentinel lymph node biopsy versus no additional staging
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Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01821768
First received: March 20, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Breast Neoplasms
Procedure: Sentinel Lymph Node Biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Regional (axillary) recurrence [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Disease free survival Arm 1 versus Arm 2. [ Time Frame: At least 5 years form date of surgery to date of any disease recurrence. ] [ Designated as safety issue: No ]
    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.

  • Overall survival Arm 1 versus Arm 2 [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 460
Study Start Date: April 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1: No sentinal lymph node biopsy
Patients will receive no additional axillary surgery which is experimental.
Active Comparator: Arm 2: Sentinel lymph node biopsy
Patients will receive standard of care sentinel lymph node biopsy
Procedure: Sentinel Lymph Node Biopsy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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 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 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.
  • Patient has undergone or plans to undergo neoadjuvant chemotherapy of endocrine therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821768

Contacts
Contact: Amy Cyr, M.D. 314-747-8708 cyra@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Amy Cyr, M.D.    314-747-8708    cyra@wudosis.wustl.edu   
Sub-Investigator: William Gillanders, M.D.         
Sub-Investigator: Natalia Tucker, M.D.         
Sub-Investigator: Timothy Eberlein, M.D.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Rebecca Aft, M.D., Ph.D.         
Sub-Investigator: Catherine Appleton, M.D.         
Sub-Investigator: Valerie Reichert, M.D.         
Sub-Investigator: Imran Zoberi, M.D.         
Sub-Investigator: Timothy Pluard, M.D.         
Sub-Investigator: Foluso Ademuyiwa, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Amy Cyr, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01821768     History of Changes
Other Study ID Numbers: 201209143
Study First Received: March 20, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014