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Molecular Marker Profiling of Axillary Lymph Nodes in Predicting Response in Patients With Locally Advanced or Metastatic Breast Cancer Who Are Undergoing Chemotherapy Followed By Surgery
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00233974
  Purpose

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
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Nuclear Scans
Drug Information available for: Fluorodeoxyglucose F18
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of molecular markers in axillary lymph node metastases with those in primary breast tumor [ Designated as safety issue: No ]
  • Changes in molecular markers in lymph nodes before and after treatment [ Designated as safety issue: No ]
  • Proportion of patients with histopathologically node-positive disease by sentinel lymph node biopsy [ Designated as safety issue: No ]
  • Rate of breast preservation [ Designated as safety issue: No ]

Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

Primary

  • Determine whether molecular markers in pretreatment axillary lymph node metastases can predict pathologic response to neoadjuvant chemotherapy in patients with locally advanced or early metastatic breast cancer.

Secondary

  • Compare molecular markers in axillary lymph node metastases with those in the primary breast tumor (obtained in protocol UNC-LCCC-9819) in patients treated with neoadjuvant chemotherapy.
  • Determine changes in molecular markers in lymph nodes before and after treatment with neoadjuvant chemotherapy in these patients.
  • Determine the proportion of clinical axillary lymph node-negative patients who have histopathologically node-positive disease identified by sentinel lymph node biopsy.
  • Determine the rate of breast preservation in patients with large breast cancers treated with neoadjuvant chemotherapy followed by fludeoxyglucose F 18 positron emission tomography probe-guided surgical resection.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer by fine needle aspiration or biopsy

    • Locally advanced or early metastatic disease
  • Clinically or radiographically measurable disease
  • Planning to receive neoadjuvant chemotherapy for locally advanced or early metastatic disease
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Not specified

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233974

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: David W. Ollila, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009