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Sacubitril/Valsartan in prevention of heart damage during breast cancer treatment
EU CTIS ID: 2024-517804-12-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Lack of Written informed consent
- Contraindications to ACE-I/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)
- 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)
See the full eligibility criteria
- 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
- Lack of Written informed consent
- Contraindications to ACE-I/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)
- 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)
- Clinically relevant HF (NYHA II-IV)
- MI within the last < 3 months
- Symptomatic hypotension or SBP < 90 mmHg
- Significant valvular disease, symptomatic coronary artery disease (CCS>2), significant AV block, symptomatic sinus node dysfunction
- Expected survival <12 months
- GFR<30 ml/min/1.73 m2 (screening visit)
- K+>5.5mmol/L (screening visit)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.