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โ† Trials
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Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients

RecruitingPhase 2Ages 18 Years - 65 YearsFemaleAin Shams University
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In plain words

What the trial is, and whether it could suit you

Breast cancer can be managed using chemotherapy, endocrine therapy and biological therapy. Treatment is determined and specified according to the characteristics of the tumor including overexpression of the human epidermal growth factor receptor (HER2). Previously patients who were diagnosed with HER2 positive breast cancer were considered of poor survival but after the discovery of trastuzumab, disease free survival among these patients was improved significantly. Though trastuzumab has made great improvement in the treatment of breast cancer, it was identified to possess a major side effect which is cardiotoxicity . Cardiotoxicity that occurs with anticancer agents is usually manifested as left ventricular dysfunction (LVD) and overt heart failure (HF). LVD was defined as a decrease in cardiac LV ejection fraction (LVEF), that is either global or more severe in the septum, symptoms of

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years old. * Newly diagnosed with early or locally advanced HER2 positive breast cancer. * Normal baseline LVEF (หƒ50%) * Planned to receive HER2-directed therapies as newadjuvant or adjuvant. Exclusion Criteria: * Elderly patients( หƒ65 years). * Primary tumors other than breast cancer. * Pregnancy and breast feeding. * Currently using cardioprotective drugs e.g.: ACEI, CCB, ARBs and another beta blocker. * Presence of diagnosed cardiomyopathy currently or in initial evaluation. * Patients with ischemic heart disease. * Contraindication for treatment with beta blockers. * Patients with hypersensitivity to nebivolol. * Poorly echogenic patients.
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What it tests

  • Nebivolol 5 mg
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Where

1 site
National Cancer Institute- Cairo University- Egypt
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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