Breast cancer patients. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention Group: Patients with HER2-positive breast cancer undergoing AC treatment will receive Sacubitril/Valsartan at a daily dose of 50 mg for a minimum of three months. These pa
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients newly diagnosed with HER2-positive breast cancer who have not received any anthracycline-containing chemotherapy regimen in the past. These patients are to be treated with an AC regimen containing 60 mg/m² of doxorubicin and 600 mg/m² of cyclophosphamide for 4-6 cycles, followed by treatment with trastuzumab. Patients are expected to receive at least three cycles of trastuzumab (typically 6 mg/kg every three weeks) alone or in combination with or after a taxane-containing regimen if necessary, following the doxorubicin regimen. Study participants must have a baseline left ventricular ejection fraction (EF) of at least 50% (=50%). They should have no history of cardiovascular diseases such as heart failure, angina, or hypertension. The patient must provide consent to participate in the study and cooperate with the protocol, which includes a monitoring period of at least three months.
Exclusion criteria
Exclusion criteria: Patients with a systolic blood pressure of less than 100 mmHg. Patients with contraindications to the use of ACE inhibitors, ARBs, and neprilysin inhibitors. Patients who experience potential side effects or allergic reactions to sacubitril/valsartan or enalapril during treatment. Patients with renal failure with a GFR of less than 45 ml/min/1.73 m². Patients with serum potassium levels higher than 5 mmol/L. Patients who have experienced adverse effects such as angioedema or cough from taking enalapril or other ACE inhibitors. Patients who develop another serious illness during the intervention and are required to receive various medications that affect the cardiovascular system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The extent of changes in left ventricular systolic function before and after the intervention. Timepoint: Before the intervention began and after three months of taking either enalapril or sacubitril/valsartan. Method of measurement: Examination of echocardiographic indices including GLS and assessment of cardiac troponin enzyme. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzadeh Moghaddas
Esfahan University of Medical Sciences
Outcome results
None listed