Printed from Voxsanity (voxsanity.com.au) — NCT05465031 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Breast Cancer Trial, Recruiting
NCT05465031
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are willing and able to give written consent to take part
- You are female and aged 18 or older
- You have been diagnosed with breast cancer confirmed by a tissue test, and your tumor has been fully tested for key markers (ER, PR, HER2, and Ki67)
- You are able to swallow and take tablets or capsules, and are willing to follow the treatment plan
- Your breast cancer is at an early to locally advanced stage (grade IA to IIIC) or has spread to only a very limited number of sites in the body (oligometastatic stage IV)
- Your treatment plan includes surgery as a main part of your care
- Your treatment plan includes chemotherapy with a type of drug called anthracyclines and/or targeted drugs for HER2-positive cancer, either before or after surgery or both
- Your general health and ability to carry out daily activities is within an acceptable range (confirm with trial site)
- Your heart pumping function is at least 50%, as measured by an ultrasound of the heart
- Your heart is in a normal, regular rhythm
Who may not be able to join:
- You have previously received anthracycline-based chemotherapy or radiotherapy to the chest area before your current cancer diagnosis
- You have heart failure that is causing noticeable symptoms in daily life (confirm with trial site)
- You have had a heart attack within the last 3 months
- You have low blood pressure or your blood pressure reading is below a certain level (confirm with trial site)
- You have significant heart valve problems, chest pain from heart disease at rest or with minimal activity, a significant heart rhythm conduction problem, or a malfunctioning heart rate node (confirm with trial site)
- Your expected survival is less than 12 months
- Your kidneys are not working well enough, based on a blood test done at your screening visit (confirm with trial site)
- Your potassium blood level is too high at your screening visit (confirm with trial site)
- You have a medical reason why you cannot take a certain group of blood pressure or heart medications (confirm with trial site)
- You have an active liver disease that is currently untreated
- You are pregnant
- You have a condition or situation that might make it difficult to follow medical advice, such as active drug or alcohol dependence or poorly managed mental health issues
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 4
Sponsor
Silesian Centre for Heart Diseases
Registry
ClinicalTrials.gov
Start date
17 April 2024
Est. completion
1 December 2027
Where this trial is recruiting
🇵🇱 Poland
Primary endpoints
Change in left ventricular ejection fraction (LVEF) by ≥5%
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.