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Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer Clinical research trials and Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
For Condition: stage 2 breast cancer,stage 3C breast cancer,stage 3A breast cancer,stage 4 breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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: Clinical trial to study the effectiveness of sentinel lymph node biopsy and primary tumor gene expression profiling in detecting lymph nodemetastases in women who have received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer.
Details: 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. Following 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidDanforth, Study Chair, Surgery Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000356050; NCI-04-C-0114
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080860
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2. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
3. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
4. HER-2 Protein Vaccine in Treating Women With Breast Cancer
5. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
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Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting 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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