Using Sacubitril/Valsartan to prevent heart damage in breast cancer treatment
Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent
This study is testing if the medication Sacubitril/Valsartan can help protect the hearts of women undergoing treatment for breast cancer from damage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Silesian Centre for Heart Diseases Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab |
| Locations | 4 sites (Opole, Opole Voivodeship and 3 other locations) |
| Trial ID | NCT05465031 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and over with early-stage breast cancer who are scheduled for radical treatment and have a baseline LVEF of 50% or higher.
Not a fit: Patients with prior anthracycline therapy, significant heart failure, or recent myocardial infarction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart damage in women undergoing treatment for breast cancer.
How similar studies have performed: While there have been attempts to prevent cardiotoxicity in cancer treatments, this specific approach using Sacubitril/Valsartan is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Opole, Opole Voivodeship and 3 other locations
- Regional Cancer Centre in Opole — Opole, Opole Voivodeship, Poland (Recruiting)
- Maria Sklodowska-Curie Institute - Oncology Centre (MSCI), Gliwice Branch — Gliwice, Silesian Voivodeship, Poland (Recruiting)
- Silesian Center for Heart Diseases — Zabrze, Silesian Voivodeship, Poland (Active_not_recruiting)
- Holy Cross Cancer Centre, Cardio-Oncology Division — Kielce, Świętokrzyskie Voivodeship, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.