Evaluating the heart protection of dapagliflozin in breast cancer patients undergoing chemotherapy
Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients
This study is testing if the medication dapagliflozin can help protect the hearts of breast cancer patients from damage while they receive chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Helwan University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06491680 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether dapagliflozin can provide cardioprotective effects against cardiotoxicity caused by anthracycline chemotherapy in breast cancer patients. Participants will receive dapagliflozin daily starting one week before their first cycle of anthracyclines and continuing until the last dose. The study will monitor the incidence of cardiotoxicity and any medical issues arising from dapagliflozin use. The trial focuses on patients with invasive breast carcinoma who are eligible for anthracycline treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 60 with invasive breast cancer who are scheduled to receive anthracycline-based chemotherapy and have adequate renal function.
Not a fit: Patients with pre-existing cardiac conditions or those who have previously received anthracycline treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce the risk of heart damage in breast cancer patients receiving anthracycline chemotherapy.
How similar studies have performed: While the cardioprotective effects of dapagliflozin are being explored, this specific application in breast cancer patients undergoing anthracycline treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, Cairo Governorate
- Al demerdash hospital at oncology departement — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Shimaa Nabil Abd elaziz Hassanein, bachelor
- Email: Shimaa.Nabil@pharm.helwan.edu.eg
- Phone: +201115817090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.