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โ† Trials
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Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)

RecruitingPhase 4Ages 18 Years - anyFemaleSilesian Centre for Heart Diseases
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In plain words

What the trial is, and whether it could suit you

Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written informed consent * Female gender, aged 18 years and over * Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (Estrogen receptor - ER, Progesterone receptor - PR, Human epidermal growth factor receptor 2 - HER2, Kiel - Ki67) * Ability to take oral medication and willingness to adhere to the planned regimen * Tumor grade IA-IIIC or oligometastatic grade IV * Radical treatment plan including surgery * Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and/or anti-HER2 drugs * Eastern Cooperative Oncology Group (ECOG) 0-2 general status * LVEF โ‰ฅ 50% as assessed by echocardiography * Sinus rhythm Exclusion Criteria: * Prior anthracycline-based chemotherapy and/or thoracic radiotherapy (prior to diagnosis of the cancer being the present cause of therapy) * Clinically relevant HF (NYHA II-IV) * Myocardial infarction (MI) within the last \< 3 months * Symptomatic hypotension or systolic blood pressure (SBP) \< 90 mmHg * Significant valvular disease, symptomatic coronary artery disease (CCS\>2), significant atrioventricular (AV) block, symptomatic sinus node dysfunction * Expected survival \<12 months * Glomerular filtration rate (GFR) \<30 ml/min/1.73 m2 (screening visit) * K+\>5.5mmol/L (screening visit) * Contraindications to angiotensin converting enzyme inhibitor (ACE-I)/angiotensin II receptor blocker (ARB) or LCZ696 if not listed among criteria * Active untreated liver disease * Pregnancy * Conditions/circumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug/alcohol dependence, poorly controlled mental illness)
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What it tests

  • Sacubitril-valsartan
  • Placebo
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Where

4 sites
Regional Cancer Centre in Opole
Opole, Poland
Maria Sklodowska-Curie Institute - Oncology Centre (MSCI), Gliwice Branch
Gliwice, Poland
Silesian Center for Heart Diseases
Zabrze, Poland
Holy Cross Cancer Centre, Cardio-Oncology Division
Kielce, Poland
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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