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Prevention of cardiac Dysfunction during Adjuvant breast cancer therapy: A Randomized, Placebo-controlled, Multicenter Trial (PRADA-II)
EU CTIS ID: 2024-515323-11-00
What this study is testing
In patients with early breast cancer scheduled for anthracycline-containing anti-cancer therapy, to assess whether the administration of LCZ696 (sacubitril/valsartan) can prevent or is associated with attenuation of the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR).
- Therapeutic exploratory (Phase II)
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
- Women with histological evidence of invasive early breast cancer scheduled for neoadjuvant and/or adjuvant therapy with anti-cancer regimens that include anthracyclines.
- Eastern Cooperative Oncology Group performance status 0-1.
- Sinus rhythm.
You likely can't join if
- Age <18 years
- History of hemodynamically significant valvular disease
- Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
- Participation in another pharmaceutical clinical trial of an investigational medicinal product less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
- Contraindication or inability to undergo CMR examination
See the full eligibility criteria
- Women with histological evidence of invasive early breast cancer scheduled for neoadjuvant and/or adjuvant therapy with anti-cancer regimens that include anthracyclines.
- Eastern Cooperative Oncology Group performance status 0-1.
- Sinus rhythm.
- Age <18 years
- History of hemodynamically significant valvular disease
- Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
- Participation in another pharmaceutical clinical trial of an investigational medicinal product less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
- Contraindication or inability to undergo CMR examination
- Fertile women with inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. Fertile women are defined as following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- Life expectancy < 12 months
- Renal failure, i.e. serum creatinine greater than 133 micromol/L (1,5 mg/dl) or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2
- Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L
- Systolic blood pressure < 100 mg Hg
- Uncontrolled hypertension
- Acute myocardial infarction within the last three months
- Contraindication to angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or LCZ696, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- ACEI, ARB, aldosterone antagonist or LCZ696 use within 4 weeks of study start
- Clear indication for ACEI, ARB, aldosterone antagonist or LCZ696 therapy, including symptomatic heart failure
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, 18-64 years, 65+ 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.