Clinical trial · Observational
Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in enrolling patients
Summary
Brief summary (as posted)
Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Herceptin
- description
- The study will be carried in prospective manner enrolling all patients diagnosed with breast cancer and over expressed human epidermal growth factor receptor 2 (HER2) and they are requiring Trastuzumab Neu adjuvant/ adjuvant /metastatic therapy as per standard care.
- interventionNames
- Drug: Herceptin
Primary outcomes (1)
- measure
- Estimate the incidence /of Herceptin induced heart failure in our population
- timeFrame
- 3 years
- description
- To evaluate the reversibility of damage in patients on long term follow- up for a period of up to three years. To identify the applicability of troponin / cardiac natriuretic peptides (CNPS) as bio marker that can predict the occurrence of clinically significant left ventricular dysfunction. To evaluate the role of MRI in identifying patient at risk to develop cardio toxicity. Determine the frequency of elevated Troponin and B-type natriuretic peptide (BNP) in patient receiving adjuvant herceptin.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH. Age 18 to 80 years old. Patient with above criteria and eligible for Neu adjuvant/ adjuvant /metastatic( Trastuzumab) Herceptin therapy. Normal blood count, liver function test and kidney function. Exclusion Criteria: Abnormal cardio vascular disease (ex. Heart Failure, Ischemic Heart Disease, post CABG) with EF≤50. Valvular abnormality with reduced ejection fraction (EF). Recent Myocardiac Infraction / Ischemia Pregnancy or Breast feeding
References
Publications (0)
Data not yet available