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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00233974 |
RATIONALE: Comparing results of diagnostic procedures, such as molecular marker profiling, done before and after chemotherapy, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well molecular marker profiling of axillary lymph nodes works in predicting response in patients with locally advanced or metastatic breast cancer who are undergoing chemotherapy followed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: fludeoxyglucose F 18 Procedure: biopsy Procedure: conventional surgery Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: positron emission tomography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Axillary Lymph Nodes and PET (Positron Emission Tomography) Probe-Guided Surgical Resection in Locally Advanced Breast Cancer Patients: Molecular Marker Profile and Response to Neoadjuvant Chemotherapy |
Study Start Date: | May 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo open surgical biopsy of axillary lymph nodes OR intraoperative lymphatic mapping and sentinel lymphadenectomy for clinically node-positive or clinically node-negative disease, respectively, before and after neoadjuvant chemotherapy. The axillary lymph node tissue is examined for molecular and protein markers by immunohistochemistry and fluorescence in situ hybridization. Patients also undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) once before and then once after neoadjuvant chemotherapy. Beginning 1 hour before surgery, patients receive an injection of FDG and then undergo conventional segmental mastectomy (lumpectomy) with or without needle localization followed by FDG-PET probe-guided surgical resection of any remaining FDG-avid tumor tissue.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer by fine needle aspiration or biopsy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 |
Principal Investigator: | David W. Ollila, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000439444, UNC-LCCC-9924 |
Study First Received: | October 5, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00233974 |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |