Clinical trial · Observational
CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC
Computed Tomography-based Radiomics of Axillary Lymph Node Pathological Complete Remission (ypN0) in Breast Cancer Undergoing Neoadjuvant Chemotherapy
NCT04457700CI-TRIAL-00057869unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a prospective, single-center, non-randomized, non-controlled observational study.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Triple-negative and HER2 Positive breast cancer
- description
- Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.
Primary outcomes (1)
- measure
- The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy
- timeFrame
- within 8 weeks after obtaining the post-surgery pathological results
- description
- Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
Secondary outcomes (1)
- measure
- Receiver operating characteristic (ROC) curve analysis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy. * Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy. * Attend the study voluntarily, sign the informed consent. Exclusion Criteria: * Contradiction for adjuvant chemotherapy. * Contradiction for proceeding surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.