Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
Data Collection
Breast Diseases+6
+ Breast Neoplasms
+ Lymphatic Metastasis
Diagnostic Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, United StatesSee the location