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

NCT ID: NCT00080860

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-08-31

Brief Summary

RATIONALE: Sentinel lymph node biopsy and gene expression profiling of the primary breast tumor may help determine if tumor cells have spread to the axillary lymph nodes and help doctors plan more effective surgery for breast cancer.

PURPOSE: This clinical trial is studying how well sentinel lymph node biopsy and primary tumor gene expression profiling work in finding lymph node metastases in women who have received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

microarray analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

conventional surgery

Intervention Type: PROCEDURE

lymphangiography

Intervention Type: PROCEDURE

radionuclide imaging

Intervention Type: PROCEDURE

sentinel lymph node biopsy

Intervention Type: PROCEDURE

technetium Tc 99m sulfur colloid

Intervention Type: RADIATION

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

David N. Danforth, MD, MS

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

04-C-0114

Identifier Type: -

Identifier Source: secondary_id

CDR0000356050

Identifier Type: -

Identifier Source: secondary_id

040114

Identifier Type: -

Identifier Source: org_study_id

NCT00076895

Identifier Type: -

Identifier Source: nct_alias