Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, male breast cancer
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.
Interventions
DRUGIsosulfan 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.
PROCEDUREAxillary Lymph Node Dissection
Axillary Lymph Node Dissection
PROCEDURESurgery
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.
PROCEDURESentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
PROCEDUREThoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
RADIATIONTechnetium 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
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Between 2001 and 2007 a prospective database was obtained of all patients undergoing internal mammary sentinel lymph node biopsies using an open or thoracoscopic approach. Radiotracer injection was peritumoral.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 50 years |
| Gender Female | 33 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 34 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Time frame: 5 years
Population: Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Biopsy | Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes | 34 participants |
Primary
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Biopsy | Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes | 7 participants |
Primary
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Biopsy | Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy | 31 participants |