Lymph Node Metastases Clinical Trial
Official title:
To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
NCT number | NCT03715686 |
Other study ID # | BCP24 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 20, 2018 |
Est. completion date | June 30, 2022 |
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.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 20, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital Breast Center | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes. | Sensitivity, specificity, false negative rate and negative predictive value will be calculated. | through study completion, an average of 1 year | |
Secondary | Model to predict lymph node pCR in cN1 patients. | Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients. | through study completion, an average of 1 year |
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