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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080860
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : March 8, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Genetic: microarray analysis Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Diagnostic
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
Study Start Date : February 2004
Actual Study Completion Date : August 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Over 18


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Hemoglobin > 7.0 g/dL
  • Platelet count > 50,000/mm^3
  • WBC > 2,000/mm^3


  • PT and PTT < 1.5 times normal


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics


  • No prior definitive breast radiotherapy to the target breast


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00080860

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: David N. Danforth, MD, MS NCI - Surgery Branch Identifier: NCT00080860     History of Changes
Obsolete Identifiers: NCT00076895
Other Study ID Numbers: 040114
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Technetium Tc 99m Sulfur Colloid
Molecular Mechanisms of Pharmacological Action