Clinical trial · Observational
Impact of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer
Application of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter Retrospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy (SLNB) following neoadjuvant systemic therapy (NST).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Test cohort | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Training cohort
- description
- Patients (n=386) who accepted neoadjuvant systemic therapy followed surgery were from fujian medical university union hospital from April 1, 2012, to May 30, 2022.
- label
- External validation cohort
- description
- Patients (n=211) who accepted neoadjuvant systemic therapy followed surgery were from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University and No. 900 Hospital of The Joint Logistic Support Force from April 1, 2012, to May 30, 2022.
- label
- Test cohort
- description
- Patients (n=119) who accepted sentinel lymph node biopsy followed axillary lymph node dissection after neoadjuvant systemic therapy was retrospectively collected from June 1,2022 to May 31, 2023.
- interventionNames
- Procedure: Test cohort
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * histologically proven primary breast cancer without distant metastatic lesions, * HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization), * initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST, * a full course of standard neoadjuvant therapy before surgery * complete clinicopathological characteristics and treatment information. Exclusion Criteria: * do not plan or are unable to operate; * with distant metastasis * do not accept full cycles or standard neoadjuvant systemic therapy * loss of clinicopathological characteristics and treatment information. * with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non-tumor related diseases who could not tolerate comprehensive treatment such as surgery and chemotherapy
References
Publications (0)
Data not yet available