Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

University of Miami

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: Axillary Lymph Node Dissection

Drug: Isosulfan blue

Procedure: Surgery

Radiation: Technetium Tc 99m Sulfur Colloid

Procedure: Sentinel Lymph Node Biopsy

Procedure: Thoracoscopic Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00450723

SCCC-2003161 (Other Identifier)

WIRB-20050911 (Other Identifier)

20040015

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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