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

Breast Cancer Clinical Trial

Official title:

Thoracoscopic Internal Mammary Sentinel Node Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450723
• Other study ID #: UMIAMI-20040015
• Secondary ID: SCCC-2003161WIRB
• Status: Completed
• Phase: N/A
• First received: March 20, 2007
• Last updated: July 25, 2014
• Start date: May 2004
• Est. completion date: March 2011

Study information

• Verified date: August 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Procedure:
• Axillary Lymph Node Dissection
Axillary Lymph Node Dissection
• 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.
• Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
• 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

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy		5 years	No
Primary	Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes		5 years	No
Primary	Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes		5 years	No