Thoracoscopic Sentinel Lymph Node Biopsy in Patients 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 thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer. Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients. Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients. OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes. All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
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Thoracoscopic Internal Mammary Sentinel Node Biopsy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Isosulfan blue
* Procedure: Axillary Lymph Node Dissection
* Procedure: Surgery
* Procedure: Sentinel Lymph Node Biopsy
* Procedure: Thoracoscopic Surgery
* Radiation: Technetium Tc 99m Sulfur Colloid


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage I or II disease (T1-T2, N0, M0/MX disease) No chest wall invasion by tumor (T3 disease) Medially or centrally located lesion No multicentric disease Multifocal disease allowed No clinically positive axillary nodes No enlarged internal mammary nodes by CT scan Hormone receptor status not specified PATIENT CHARACTERISTICS: Male or female Menopausal status not specified American Society of Anesthesiologists (ASA) physical status classification 1-2 Not pregnant or nursing Negative pregnancy test No other concurrent known, invasive malignancy No known chronic pulmonary disease No known allergy to methylene blue or isosulfan blue PRIOR CONCURRENT THERAPY: No prior thoracic or cardiac surgery No prior ipsilateral chest tube placement Contralateral chest tube placement allowed No prior neoadjuvant chemotherapy No prior radiotherapy to the mediastinum

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel Lymph Node Biopsy<br> | Drug: Isosulfan blue<br>* Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.<br>* Other names: Lymphazurin;Procedure: Axillary Lymph Node Dissection<br>* Axillary Lymph Node Dissection<br>Procedure: Surgery<br>* The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.<br>Procedure: Sentinel Lymph Node Biopsy<br>* Sentinel Lymph Node Biopsy<br>Procedure: Thoracoscopic Surgery<br>* Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.<br>Radiation: Technetium Tc 99m Sulfur Colloid<br>* Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy |  | 5 years | 
| Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes |  | 5 years | 
| Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes |  | 5 years | 

 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, male breast cancer