Evaluating the heart protection of dapagliflozin in breast cancer patients undergoing chemotherapy
Official title: Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients
Run by Helwan University · NCT06491680 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Helwan University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | September 10, 2024 |
| Main results expected | October 2025 |
| Study ends | June 2026 |
| Registry record updated | September 22, 2025 |
| Trial ID | NCT06491680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with pre-existing cardiac conditions or those who have previously received anthracycline treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the cardioprotective effects of dapagliflozin are being explored, this specific application in breast cancer patients undergoing anthracycline treatment is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.