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

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Breast Neoplasms

Treatments: Procedure: Sentinel Lymph Node Biopsy; Procedure: Fine needle aspiration biopsy (FNAB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00360152

06-0530 / 201109077

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Positive Axillary Ultrasound

Active Comparator group

Description:

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

Treatment:

Procedure: Sentinel Lymph Node Biopsy

Procedure: Fine needle aspiration biopsy (FNAB)

Negative Axillary Ultrasound

Active Comparator group

Description:

Negative Axillary Ultrasound -\> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -\> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology

Treatment:

Procedure: Sentinel Lymph Node Biopsy

Procedure: Fine needle aspiration biopsy (FNAB)