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Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer


OBJECTIVES:

- Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node
status after neoadjuvant therapy in women with stage II, III, or IV breast cancer.

- Correlate gene expression profiling of the primary breast cancer with axillary and
sentinel lymph node status in these patients.

OUTLINE: This is a pilot study.

After neoadjuvant chemotherapy, patients undergo sentinel lymph node (SLN) mapping
comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify
the SLN. Within 1-2 hours after injection, patients undergo SLN biopsy followed immediately
by definitive local surgery comprising modified radical mastectomy or breast segmentectomy
with axillary lymph node dissection. SLN and axillary lymph nodes are examined by
hematoxylin and eosin (H & E) staining for the presence or absence of metastases. If the
lymph nodes are negative for tumor by H & E, the lymph nodes are further analyzed by
immunohistochemistry. The primary tumor is analyzed by microarray analysis for gene
expression profile determinations.

Patients are followed at 2-3 weeks after surgery.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed carcinoma of the breast

- Stage II, III, or IV infiltrating disease

- Unilateral or bilateral AND unifocal or multifocal disease

- Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal
therapy, and/or biologic therapy) AND had any of the following responses:

- Clinical complete response, partial response, no change, or disease progression

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- Over 18

Sex

- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin > 7.0 g/dL

- Platelet count > 50,000/mm^3

- WBC > 2,000/mm^3

Hepatic

- PT and PTT < 1.5 times normal

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- No prior definitive breast radiotherapy to the target breast

Surgery

- No prior axillary surgery on the side of the sentinel lymph node

Other

- More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission
tomography scan, or MUGA scan)

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

David N. Danforth, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

040114

NCT ID:

NCT00080860

Start Date:

February 2004

Completion Date:

August 2007

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182