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
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
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.
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.
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