Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
| Registry | NCT00080860 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; diagnostic |
| Enrollment | 60 (Estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) (Nih); collaborators: National Cancer Institute (NCI) |
| Conditions | Breast Cancer |
| Interventions | microarray analysis, immunohistochemistry staining method, conventional surgery, lymphangiography, radionuclide imaging, sentinel lymph node biopsy, technetium Tc 99m sulfur colloid (Genetic, other, procedure, radiation) |
| Dates | start 2004-02-01, completion 2007-08-01, first posted 2004-04-08, last updated 2012-03-08 |
| Locations | 1 site in United States |
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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.
Sex: Female, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland | United States |