Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Finding Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Treatment	Closed	Over 18	NCI	NCI-04-C-0114 NCT00080860

Objectives

1. 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.
2. Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients.

Entry 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

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)

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/mm³
• WBC > 2,000/mm³

Hepatic

• PT and PTT < 1.5 times normal

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

David Danforth, MD, MS, Protocol chair		Ph: 301-496-1533 Email: david_danforth@nih.gov

Registry Information
Official Title		Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
Trial Start Date		2004-02-10
Trial Completion Date		2008-12-12 (estimated)
Registered in ClinicalTrials.gov		NCT00080860
Date Submitted to PDQ		2004-02-10
Information Last Verified		2007-12-10

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