Completed

Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Finding Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer

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What is being tested

microarray analysis

+ immunohistochemistry staining method
+ conventional surgery
Genetic
Other
Procedure
Radiation
Who is being recruted

Breast Cancer

Over 18 Years
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2004

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 8, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: Sentinel lymph node biopsy and gene expression profiling of the primary breast tumor may help determine if tumor cells have spread to the axillary lymph nodes and help doctors plan more effective surgery for breast cancer. PURPOSE: This clinical trial is studying how well sentinel lymph node biopsy and primary tumor gene expression profiling work in finding lymph node metastases in women who have received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer. OBJECTIVES: * Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node status after neoadjuvant therapy in women with stage II, III, or IV breast cancer. * Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients. OUTLINE: This is a pilot study. After neoadjuvant chemotherapy, patients undergo sentinel lymph node (SLN) mapping comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify the SLN. Within 1-2 hours after injection, patients undergo SLN biopsy followed immediately by definitive local surgery comprising modified radical mastectomy or breast segmentectomy with axillary lymph node dissection. SLN and axillary lymph nodes are examined by hematoxylin and eosin (H \& E) staining for the presence or absence of metastases. If the lymph nodes are negative for tumor by H \& E, the lymph nodes are further analyzed by immunohistochemistry. The primary tumor is analyzed by microarray analysis for gene expression profile determinations. Patients are followed at 2-3 weeks after surgery. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.

Official TitleEfficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer 
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 8, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed carcinoma of the breast * Stage II, III, or IV infiltrating disease * Unilateral or bilateral AND unifocal or multifocal disease * Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal therapy, and/or biologic therapy) AND had any of the following responses: * Clinical complete response, partial response, no change, or disease progression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Hemoglobin \> 7.0 g/dL * Platelet count \> 50,000/mm\^3 * WBC \> 2,000/mm\^3 Hepatic * PT and PTT \< 1.5 times normal Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * No prior definitive breast radiotherapy to the target breast Surgery * No prior axillary surgery on the side of the sentinel lymph node Other * More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission tomography scan, or MUGA scan)



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, United StatesSee the location

CompletedOne Study Center