Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes

This study has been completed.
Sponsor:
Collaborators:
Society for Surgical Oncologists
Sysmex America, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00360152
First received: August 2, 2006
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitations, and we believe that alternative strategies for staging of the axilla should be explored. The hypothesis of this proposal is that the combination of preoperative high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR) represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle study. In the short term, validation of this innovative strategy is likely to reduce the number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately replace SLNB.


Condition Intervention Phase
Breast Neoplasms
Procedure: Fine needle aspiration biopsy (FNAB)
Procedure: Sentinel Lymph Node Biopsy
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Minimally Invasive Staging of the Axilla in Breast Cancer: A Pilot Study to Assess the Feasibility of Axillary Ultrasound, Fine Needle Aspiration Biopsy and Molecular Analysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Determine the sensitivity of AUS and real-time RT-PCR/RT-LAMP to predict the pathologic status of the axilla in breast cancer patients [ Time Frame: At the time of ultrasound guidance and during definitive surgery for cancer ] [ Designated as safety issue: No ]
  • Determine the feasibility of AUS, FNAB, and RT-PCR/RT-LAMP as an alternative to SLNB for axillary staging of breast cancer patients [ Time Frame: At the time of ultrasound guidance and during definitive surgery for cancer ] [ Designated as safety issue: No ]
  • Define baseline gene expression levels in lymph nodes by RT-PCR/RT-LAMP in patients with no evidence of malignancy undergoing procedures under general anesthesia [ Time Frame: At the time of procedure under general anesthesia ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2006
Study Completion Date: April 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Positive Axillary Ultrasound
Positive Axillary Ultrasound -> Fine Needle Aspiration Biopsy -> Cytopathology and Reverse Transcription-Polymerase Chain Reaction (RT-PCR) -> Positive Cyto=Axillary Lymph Node Dissection, Negative Cyto=Sentinel Lymph Node Biopsy -> Pathology
Procedure: Fine needle aspiration biopsy (FNAB) Procedure: Sentinel Lymph Node Biopsy
Active Comparator: Negative Axillary Ultrasound
Negative Axillary Ultrasound -> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology
Procedure: Fine needle aspiration biopsy (FNAB) Procedure: Sentinel Lymph Node Biopsy

  Eligibility

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

Inclusion Criteria:

  • Female patients, aged 18 and over.
  • Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.

Exclusion Criteria:

  • Inability to give informed consent
  • Contraindications for breast surgery or biopsy

Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:

  • Female patients, aged 18 and over
  • Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
  • Patient must be willing to give informed consent
  • Patient with no history of malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360152

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Society for Surgical Oncologists
Sysmex America, Inc.
Investigators
Principal Investigator: Julie A. Margenthaler, M.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Parker SH, Dennis MA, Kaske TI. 2000. Identification of the sentinel nodes in patients with breast cancer. Radiol Clin North Am 38:809-823.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00360152     History of Changes
Other Study ID Numbers: 06-0530 / 201109077
Study First Received: August 2, 2006
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Axilla
Ultrasound
FNA
Molecular Analysis

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

ClinicalTrials.gov processed this record on April 17, 2014