Sacubitril/Valsartan in prevention of heart damage during breast cancer treatment
Key facts
- Where
- Gdansk, Gliwice, Kielce, Opole és Zabrze, LengyelországSee the 5 sites
- Phase
- 3. fázis
Where in Lengyelország
- Medical University Of GdanskGdansk, LengyelországTaking people
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, LengyelországTaking people
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, LengyelországTaking people
- Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki ZdrowotnejOpole, LengyelországTaking people
- Śląskie Centrum Chorób Serca w ZabrzuZabrze, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Slaskie Centrum Chorob Serca W Zabrzu
- Trial code
- EU 2024-517804-12-00
- Record updated
- 2025. október 26.
- Original description
Estimation of whether prophylactic use of sacubitril/valsartan will prevent cardiotoxicity associated with systemic breast cancer treatment, defined as a decrease in left ventricular ejection fraction ≥ 5% in an ultrasound scan during 24 months from randomization.Read full original descriptionShow less
Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent. Randomized, multicenter, double-blind, placebo-controlled study.
Estimation of whether prophylactic use of sacubitril/valsartan will prevent cardiotoxicity associated with systemic breast cancer treatment, defined as a decrease in left ventricular ejection fraction ≥ 5% in an ultrasound scan during 24 months from randomization.
Inclusion: Written informed consent; Sinus rhythm; Female gender, aged 18 years and over; Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (ER, PR, HER2, 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 or post-radical surgical treatment; Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and/or anti-HER2 drugs; ECOG 0-2 general status; LVEF ≥ 50% as assessed by echocardiography.
Exclusion: Prior anthracycline-based chemotherapy and/or left-sided radiotherapy (prior to diagnosis of the cancer being the present cause of XML File Identifier: xW+Ea9mm17kcx3fLB1UWMlFS0h4=Page 16/27 therapy); Active untreated liver disease; Conditions/circumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug/alcohol dependence, poorly controlled mental illness); Significant valvular disease, symptomatic coronary artery disease (CCS>2), significant AV block, symptomatic sinus node dysfunction; GFR<30 ml/min/1.73 m2 (screening visit); Lack of Written informed consent; Contraindications to ACE-I/ARB or LCZ696 if not listed among criteria; Pregnancy; Clinically relevant HF (NYHA II-IV); MI within the last < 3 months; Symptomatic hypotension or SBP < 90 mmHg; Expected survival <12 months; K+>5.5mmol/L (screening visit).