Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer. PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification. Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs. Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid. Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection. Patients are followed for disease evolution. PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Official Title
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French Randomized Sentinel Node Multicentric Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: patent blue V dye
* Procedure: radionuclide imaging
* Procedure: sentinel lymph node biopsy
* Radiation: technetium Tc 99m sulfur colloid


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed invasive breast cancer T0, T1, or T2 no greater than 3 cm, N0 Amenable to surgery No inflammatory breast cancer No ductal cancer in situ or multicentric invasive ductal cancer No nipple/areola or central breast cancer (at least 2 cm from areola) No metastatic disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Not specified Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant Negative pregnancy test No known allergy or intolerance to patent blue V dye PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior surgery for cancer Other No prior neoadjuvant treatment for cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Diagnostic
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: patent blue V dye|nan|
|Procedure: radionuclide imaging|nan|
|Procedure: sentinel lymph node biopsy|nan|
|Radiation: technetium Tc 99m sulfur 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