Clinical trial · Observational
CADY Study ICORG 08-01
Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY 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)
RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction. PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart dysfunction in women with breast cancer treated with trastuzumab.
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 |
| Cardiac Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Cardiac biomarker levels in predicting cardiac dysfunction
- timeFrame
- End of trial
- measure
- Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers
- timeFrame
- End of trial
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation. 2. Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab. 3. 18 years of age or older. 4. Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study. 5. As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion. 6. Treatment with curative intent. 7. ECOG Performance status 0, 1 or 2. 8. Adequate cardiac function, with MUGA or Echocardiograph \> 50%. 9. Written informed consent. Exclusion Criteria: 1. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial. 2. Evidence of metastatic disease. 3. Patients with uncontrolled hypertension (sustained systolic blood pressure \>180mmHg or diastolic blood pressure \>100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication. 4. Prior anthracycline or Trastuzumab therapy. 5. Inability to give informed consent for any reason.
References
Publications (0)
Data not yet available