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

NCT00080860 | Completed

• 3 other identifiers: 04011404-C-0114CDR0000356050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Interventions

microarray analysis GENETIC

immunohistochemistry staining method OTHER

conventional surgery PROCEDURE

lymphangiography PROCEDURE

radionuclide imaging PROCEDURE

sentinel lymph node biopsy PROCEDURE

technetium Tc 99m sulfur colloid RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Microarray Analysis; Immunohistochemistry; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Study Officials

• David N. Danforth, MD, MS

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: February 1, 2004
• Study Completion: August 1, 2007
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (1)