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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Isosulfan blue; Procedure: Axillary Lymph Node Dissection; Procedure: Surgery; Procedure: Sentinel Lymph Node Biopsy; Procedure: Thoracoscopic Surgery; Radiation: Technetium Tc 99m Sulfur Colloid

• Registration Number: NCT00450723
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-22
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Results First Submitted: 2013-01-22
• Results First Submitted QC: 2013-02-26
• Results First Posted: 2013-04-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Biopsy	Thoracoscopic Surgery	-
Sentinel Lymph Node Biopsy	Axillary Lymph Node Dissection	-
Sentinel Lymph Node Biopsy	Surgery	-
Sentinel Lymph Node Biopsy	Sentinel Lymph Node Biopsy	-
Sentinel Lymph Node Biopsy	Technetium Tc 99m Sulfur Colloid	-
Sentinel Lymph Node Biopsy	Isosulfan blue	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami; 🇺🇸 Miami, Florida, United States