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Prevention study for Breast Cancer
Official title Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)
ClinicalTrials.gov ID: NCT05465031
What this study is testing
What is Sacubitril-valsartan?
Sacubitril-valsartan is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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
- 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...
- Expected survival \<12 months
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Opole, Opole Voivodeship, Poland
- Gliwice, Silesian Voivodeship, Poland
- Zabrze, Silesian Voivodeship, Poland
- Kielce, Świętokrzyskie Voivodeship, Poland
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Opole, Opole Voivodeship, Poland; Gliwice, Silesian Voivodeship, Poland; Zabrze, Silesian Voivodeship, Poland; Kielce, Świętokrzyskie Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.