Breast cancer stage I-III, HER2 positive. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: Patients in the intervention group receive standard therapy (sequential anthracycline-taxane chemotherapy plus trastuzumab for one year) along with one daily tablet
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The patients visiting the Radio-Oncology Clinic of the Shiraz University of Medical sciences(SUMS) with recently diagnosed HER?-positive breast cancer in the stages I to III Patients that sign the consent letter They are candidates for trastuzumab therapy
Exclusion criteria
Exclusion criteria: Previous history of cardiomyopathy, uncontrolled hypertension and cardiac structural disorders Left ventricular EF < ??% or history of proved heart failure Any contraindication for beta blocker consumption such as symptomatic bradycardia, Asthma and cardiac conduction disorders Those who are already taking beta blockers History of myocardial infarction Patients with a positive history of chest radiotherapy Previous cancer chemotherapy Patients with Glomerular Filtration Rate (GFR) <?? ml/min/?.??m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trastuzumab-induced cardiotoxicity. Timepoint: Before intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention. Method of measurement: Two-dimensional echocardiography (Simpson’s method).;Left ventricular ejection fraction. Timepoint: Before intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention. Method of measurement: Two-dimensional echocardiography (Simpson’s method).;Symptomatic heart failure. Timepoint: Before intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention. Method of measurement: Clinical examination and classification.;Discontinuation of trastuzumab due to cardiac complications. Timepoint: Before intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention. Method of measurement: Medical record review and drug discontinuation documentation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNezhat Khanjani
Shiraz University of Medical Sciences
Outcome results
None listed