Clinical trial NCT03715686: To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
Official title: To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm, Breast
Neoadjuvant Chemotherapy
Lymph Node Metastases
Response
Keywords: Neoplasm, Breast
neoadjuvant chemotherapy
Lymph Node Metastases
response
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Model to predict lymph node pCR in cN1 patients.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital Breast Center
Study officials:
affiliation: Beijing Cancer Hosptial
name: Tao Ouyang, Dr.
role: STUDY_DIRECTOR
References: