Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease. PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer. OUTLINE: Patients are stratified according to node status (positive vs negative). Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection. Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye injection. All lymph nodes that stain blue or have a high radioactive count are removed. The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection. Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph node biopsy and axillary dissection proceed as above. PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.

Official Title
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Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: patent blue V dye
* Procedure: conventional surgery
* Procedure: lymphangiography
* Procedure: radionuclide imaging
* Procedure: sentinel lymph node biopsy
* Radiation: Technetium Tc 99m human serum albumin colloid


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage I or II invasive breast cancer by triple assessment: Clinically Mammogram and/or ultrasound Fine needle cytology Resectable disease by either wide local excision or mastectomy with axillary dissection No ductal carcinoma in situ Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No known allergy to vital blue dye No mental illness or handicap that would preclude study entry No other severe illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: patent blue V dye|nan|
|Procedure: conventional surgery|nan|
|Procedure: lymphangiography|nan|
|Procedure: radionuclide imaging|nan|
|Procedure: sentinel lymph node biopsy|nan|
|Radiation: Technetium Tc 99m human serum albumin colloid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer