Trial Information

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

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.