2024-517804-12-00RecruitingPhase 3
Sacubitril/Valsartan in prevention of heart damage during breast cancer treatment
Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent. Randomized, multicenter, double-blind, placebo-controlled study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 17 Apr 2024
- Lead sponsor
- Slaskie Centrum Chorob Serca W Zabrzu
- Diseases
- Heart failure
- EU CT number
- 2024-517804-12-00
- EudraCT number
- 2022-003046-13
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with breast cancer who are going to get anthracyclines and/or anti-HER2 drugs and still have normal heart function. It tests whether sacubitril/valsartan can prevent heart damage from the treatment.
- Age
- 18 years and over
- Sex
- Women only
- Disease stage
- Breast cancer confirmed by tissue test, stage IA-IIIC or oligometastatic stage IV, with a plan for radical treatment. General health status ECOG 0-2.
- Earlier treatment
- A plan to use anthracyclines and/or anti-HER2 drugs. No earlier anthracycline chemotherapy and no earlier left-sided radiotherapy.
- Biomarker or test result
- Tumor tests done (ER, PR, HER2, Ki67). Heart pumping function (LVEF) of 50% or more on an ultrasound scan. Sinus rhythm.
Main reasons for not taking part
- Pregnancy
- Heart failure with symptoms (NYHA II-IV)
- Heart attack within the last 3 months
- Kidney function GFR below 30 ml/min/1.73 m2 or potassium above 5.5 mmol/L
- Expected survival under 12 months
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Lab values
- GFR<30 ml/min/1.73 m2 (screening visit)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Of Gdansk | Gdansk | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Gliwice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach | Kielce | Poland | Recruiting |
| Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Opole | Poland | Recruiting |
| Śląskie Centrum Chorób Serca w Zabrzu | Zabrze | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.