Clinical trial · Interventional
Cardiotoxicity in Breast Cancer Patients
Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dapagliflozin group
- description
- Dapagliflozin group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) with dapagliflozin 10 mg tablet once daily.
- interventionNames
- Drug: Dapagliflozin 10mg Tab
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) only.
Primary outcomes (1)
- measure
- N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing
- timeFrame
- Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months from baseline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available