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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00450723
First received: March 20, 2007
Last updated: August 13, 2013
Last verified: August 2013
  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
Procedure: Axillary Lymph Node Dissection
Procedure: Surgery
Procedure: Sentinel Lymph Node Biopsy
Procedure: Thoracoscopic Surgery
Radiation: Technetium Tc 99m Sulfur Colloid

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Thoracoscopic Internal Mammary Sentinel Node Biopsy

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: May 2004
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sentinel Lymph Node Biopsy Drug: Isosulfan blue
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.
Other Name: Lymphazurin
Procedure: Axillary Lymph Node Dissection
Axillary Lymph Node Dissection
Procedure: Surgery
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.
Procedure: Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
Procedure: Thoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Radiation: Technetium Tc 99m Sulfur Colloid
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

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
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Eli Avisar, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00450723     History of Changes
Other Study ID Numbers: UMIAMI-20040015, SCCC-2003161, WIRB-20050911
Study First Received: March 20, 2007
Results First Received: January 22, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 21, 2014