Clinical trial NCT00450723: Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Official title: Thoracoscopic Internal Mammary Sentinel Node Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
male breast cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
timeFrame: 5 years
measure: Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
timeFrame: 5 years
measure: Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Eli Avisar, MD
role: STUDY_CHAIR
References:
citation: Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.