Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/21/2018 |
| Start Date: | April 7, 2017 |
| End Date: | July 2019 |
| Contact: | Yoana P Avitan |
| Email: | yoana@med.unc.edu |
| Phone: | 919.966.6715 |
The purpose of this research study is to determine how feasible and accurate identifying and
removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is
when patients present with breast cancer that has spread to lymph nodes in the axilla. The
specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves
that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for
future removal. That lymph node will be removed after systemic therapy and compared with the
rest of the lymph nodes removed from that region.
removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is
when patients present with breast cancer that has spread to lymph nodes in the axilla. The
specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves
that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for
future removal. That lymph node will be removed after systemic therapy and compared with the
rest of the lymph nodes removed from that region.
Inclusion Criteria:
1. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum
three abnormal axillary nodes on ultrasound exam) M0.
2. Core needle biopsy (or fine needle aspiration (FNA)) of an axillary node documenting
nodal disease at time of diagnosis and prior to preoperative systemic therapy or
surgery. Clinical care marker clip placed in the abnormal axillary nodes identified at
ultrasound at the time of core needle or FNA of an axillary node that documented nodal
disease.
3. Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it)
prior to the surgical intervention.
4. No prior axillary lymph node surgery for pathological confirmation of axillary status.
5. No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.
6. Females of childbearing potential must have a negative serum pregnancy test within 14
days prior to receipt of chemotherapy. NOTE: Females are considered of child bearing
potential unless they are surgically sterile (have undergone a hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at
least 12 consecutive months
7. Females of childbearing potential must be willing to abstain from heterosexual
activity or to use 2 forms of effective methods of contraception from the time of
informed consent until 30 days after chemotherapy discontinuation. The two
contraception methods can be comprised of two barrier methods, or a barrier method
plus a hormonal method or an intrauterine device that meets <1% failure rate for
protection from pregnancy in the product label.
8. As determined by the enrolling physician or protocol designee, ability of the subject
to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
1. Active infection requiring systemic therapy
2. Has a known additional malignancy that is active and/or progressive requiring
treatment; exceptions include basal cell or squamous cell skin cancer, in situ
cervical or bladder cancer.
3. Any distant metastasis by imaging and biopsy (cM1)
4. Patients not receiving neoadjuvant systemic therapy.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Kristalyn Gallagher, DO
Phone: 919-966-6715
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