Clinical trial · Observational
Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
NCT04962425CI-TRIAL-00052714unknownClinicalTrials.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)
According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antitumor Drugs | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- The case group
- description
- Trastuzumab for the treatment of breast cancer patients with cardiotoxicity.
- interventionNames
- Drug: Trastuzumab
- label
- The control group
- description
- Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity
- interventionNames
- Drug: Trastuzumab
Primary outcomes (4)
- measure
- Cardiac toxicity
- timeFrame
- 12 months
- description
- The asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value \< 50%
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients diagnosed with HER2-positive breast cancer treated in our hospital. 2. Surgical treatment combined with chemotherapy or radiotherapy was completed according to NCCN guidelines, and trastuzumab standard treatment was received for at least half a year. (3) Cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests. (4) Complete case data. Exclusion Criteria: 1. Patients who have not been properly treated with trastuzumab or have been treated for less than half a year; 2. Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment; 3. Patients whose case data were missing or lost to follow-up.
References
Publications (0)
Data not yet available
No reference posted for this study.