Breast Cancer, Locally Advanced Breast Cancer
Conditions
Keywords
Sentinel Lymph Node Biopsy, 17-384
Brief summary
This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.
Interventions
PROCEDURESentinel Lymph Node Biopsy (SLNB)
Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a prospective single-arm study design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients over 18 years of age with biopsy-proven breast cancer * Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging * Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies * Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam
Exclusion criteria
* Patients with a prior history of ipsilateral breast cancer * Pregnant patients * Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam * Patients not consenting to ALND
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer | 3 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Barrio, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed