N/A
N=39
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00450723 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy — 31 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Isosulfan blue (Drug); Axillary Lymph Node Dissection (Procedure); Surgery (Procedure); Sentinel Lymph Node Biopsy (Procedure); Thoracoscopic Surgery (Procedure); Technetium Tc 99m Sulfur Colloid (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy |
31 | — |
| PRIMARY Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes |
7 | — |
| PRIMARY Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes |
34 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00450723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.