Status:
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
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 eff...
Detailed Description
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 ge...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00080860
Start Date
February 1 2004
End Date
August 1 2007
Last Update
March 8 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182