Status:
COMPLETED
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Lead Sponsor:
University of Miami
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
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 be...
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, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00450723
Start Date
May 1 2004
End Date
March 1 2011
Last Update
February 7 2017
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136