Lymph Node Metastases, Neoadjuvant Chemotherapy, Neoplasm, Breast, Response
Conditions
Keywords
Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response
Brief summary
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
Detailed description
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC \>0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.
Interventions
PROCEDUREwire localization
Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.
Sponsors
Peking University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* between the age of 18 and 65 * Eastern Cooperative Oncology Group (ECOG) score 0 or 1 * pathologically proven positive axillary lymph node * enough renal and liver function to sustain chemotherapy * informed consent obtained
Exclusion criteria
* inflammatory breast cancer * being pregnant or nursing * neoadjuvant chemotherapy not planned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes. | through study completion, an average of 1 year | Sensitivity, specificity, false negative rate and negative predictive value will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Model to predict lymph node pCR in cN1 patients. | through study completion, an average of 1 year | Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients. |
Countries
China
Contacts
Primary ContactXinguang Wang, Dr.
Backup ContactZhaoqing Fan, Dr.
Outcome results
None listed