Using Sacubitril/Valsartan to prevent heart damage in breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Sacubitril/Valsartan in preventing cardiotoxicity associated with systemic breast cancer treatments. It is a multicenter, randomized, placebo-controlled trial involving approximately 600 patients across three Polish oncology centers. Participants will be randomly assigned to receive either the medication or a placebo, and their heart function will be monitored through echocardiography over a 24-month period. The primary endpoint is the occurrence of a significant decrease in left ventricular ejection fraction (LVEF).

Why it matters

Who can join: the full rules

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 ≥ 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)

Where it's running

• Regional Cancer Centre in Opole
  Opole, Opole Voivodeship, Poland Recruiting
• Maria Sklodowska-Curie Institute - Oncology Centre (MSCI), Gliwice Branch
  Gliwice, Silesian Voivodeship, Poland Recruiting
• Holy Cross Cancer Centre, Cardio-Oncology Division
  Kielce, Świętokrzyskie Voivodeship, Poland Recruiting
• Silesian Center for Heart Diseases
  Zabrze, Silesian Voivodeship, Poland Active not recruiting

Study contacts

• Principal investigator: Mateusz Tajstra — 3rd Department of Cardiology, School of Medical Sciences in Zabrze, Medical University of Silesia, Katowice; Silesian Center for Heart Diseases
• Study coordinator: Mateusz Tajstra, MD, PhD, Assoc Prof
• Email: mateusztajstra@wp.pl
• Phone: +48323733860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.