Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer - Full Text View

Sponsored by:	Sylvester Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00450723

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: isosulfan blue Drug: technetium Tc 99m sulfur colloid Procedure: axillary lymph node dissection Procedure: conventional surgery Procedure: sentinel lymph node biopsy Procedure: thoracoscopic surgery Procedure: videothoracoscopy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Iso-sulfan blue

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Thoracoscopic Internal Mammary Sentinel Node Biopsy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Occurrence rate of internal mammary sentinel lymph nodes (SLNs) by thoracoscopy [ Designated as safety issue: No ]
Success rate in removing SLNs by thoracoscopy [ Designated as safety issue: No ]
Rate of metastatic disease in internal mammary SLNs [ Designated as safety issue: No ]
Node identification time [ Designated as safety issue: No ]
Duration of thoracoscopic procedure [ Designated as safety issue: No ]
Frequency and severity of complications [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2004
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450723

Locations

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com

Sponsors and Collaborators

Sylvester Cancer Center

Investigators

Study Chair:

Eli Avisar, MD

Sylvester Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000537493, SCCC-2003161, SCCC-20050911, SCCC-20040015
Study First Received:	March 20, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00450723
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
male breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009