NCT06491680 Cardiotoxicity in Breast Cancer Patients
| NCT ID | NCT06491680 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Helwan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-09-10 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug. Aim of the study: Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity. The main questions it aims to answer are: 1. Does the drug lower the cardiotoxicity which induced by anthracyclines? 2. What medical problems do participants have when taking dapagliflozin drug? Treatment 1. Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination. 2. Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.
Eligibility Criteria
Inclusion Criteria: 1. patients with pathologically proved invasive breast carcinoma. 2. Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines. 3. Renal function (eGFR \> 30 mL/minute per 1.73 m2 ) 4. LVEF is more than 50 % 5. Age ≥ 18 and ≤ 60 years old Exclusion Criteria: 1. patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction. 2. Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens 3. pregnant or breastfeeding patients 4. patients receiving any other cardiotoxic agents. 5. Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus. 6. Mediastinal irradiation including heart. 7. Refusal to sign the written informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06491680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06491680 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06491680 currently recruiting?
Yes, NCT06491680 is actively recruiting participants. Contact the research team at Shimaa.Nabil@pharm.helwan.edu.eg for enrollment information.
Where is the NCT06491680 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06491680 clinical trial?
NCT06491680 is sponsored by Helwan University. The trial plans to enroll 40 participants.
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