Axillary Lymph Node Dissection, Breast Cancer
Conditions
Keywords
Breast, Lymph Nodes
Brief summary
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
Interventions
RADIATIONisosulfan blue dye
At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies day of mapping for patient convenience.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND. * Females \> 21 years of age
Exclusion criteria
* Prior ipsilateral axillary surgery * Prior ipsilateral axillary radiation * Prior ipsilateral breast cancer * Prior ipsilateral breast radiation * Allergy to isosulfan blue dye * History of ipsilateral upper extremity lymphedema * Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast * Prior history of neoadjuvant chemotherapy for current breast cancer * Bulky axillary disease at presentation (N2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Upper Extremity Lymphatic Mapping for Breast Cancer Patients Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Treatment Failure | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Upper Extremity Lymphatic Mapping for Breast Cancer Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Upper Extremity Lymphatic Mapping for Breast Cancer Patients | Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). | 0 participants |