Dapagliflozin to prevent heart damage from doxorubicin in breast cancer

Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients

This trial will test if taking dapagliflozin can prevent heart damage in adults with early-stage breast cancer who are receiving doxorubicin chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Tanta University (Academic / other)
• Drugs / interventions: doxorubicin
• Locations: 1 site (Alexandria, Bab Sharqi)
• Trial ID: NCT06427226 on ClinicalTrials.gov

What this trial studies

This phase 2 randomized controlled trial gives adults with stage I–III, chemo‑naïve breast cancer either dapagliflozin 10 mg or control while they receive at least four cycles of doxorubicin. Participants must have normal baseline heart function (LVEF ≥55%) and adequate hematologic, liver, and kidney function, and will be monitored with cardiac imaging and safety labs during and after chemotherapy. The trial aims to determine whether dapagliflozin is safe in this setting and can reduce signs of doxorubicin‑related cardiotoxicity. The study is led by Tanta University with site visits at the Medical Research Institute in Alexandria, Egypt.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with biopsy‑confirmed stage I–III breast cancer who are chemo‑naïve, scheduled to receive at least four cycles of doxorubicin, have LVEF ≥55%, and adequate hematologic, liver, and kidney function.

Not a fit: Patients with metastatic disease, prior recent anthracycline exposure, baseline reduced LVEF, age under 18 or over 65, current SGLT2 inhibitor use, or significant renal impairment are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could lower the risk of chemotherapy‑related heart damage and help patients complete lifesaving anthracycline therapy with better long‑term cardiac function.

How similar studies have performed: SGLT2 inhibitors like dapagliflozin have proven cardiovascular benefits in heart failure, but their use specifically to prevent anthracycline‑induced cardiotoxicity is mostly supported by preclinical data and early clinical work rather than established large trials.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old.
* Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients intended to receive at least 4 cycles of doxorubicin or more.
* Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
* Echocardiographic LVEF ≥55%.
* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
* Patients with adequate liver function and adequate renal function.
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Age \<18 years old and \>65 years old.
* Patients with prior exposure to anthracyclines within the last 6 months.
* Patients with evidence of metastasis at initial assessment.
* Treatment with any SGLT-2 inhibitors for 6 months prior to the screening.
* Patients taking any other cardioprotective medications.
* Pregnancy and breast feeding.
* Alcohol abuse.
* History of heart failure or LVEF \<50%.
* Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
* Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.

Where this trial is running

Alexandria, Bab Sharqi

• Medical Research Institute — Alexandria, Bab Sharqi, Egypt (Recruiting)

Study contacts

• Principal investigator: Sandy E Rezkallah, bachelor — Tanta University
• Study coordinator: Sandy Rezkallah, Bachelor

Conditions Doxorubicin Induced Cardiomyopathy; Breast Cancer