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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


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer

Thank you

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improved breast conservation rates in neoadjuvant patients

Outcome Description:

Determine if an intraoperative positron emission tomography (PET) probe can improve breast conservation rates in patients treated initially with neoadjuvant chemotherapy by at least 2%.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

David W. Ollila, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 9924

NCT ID:

NCT00233974

Start Date:

May 2002

Completion Date:

March 2006

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570