Dapagliflozin to prevent heart damage from doxorubicin in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical Research Institute
  Alexandria, Bab Sharqi, Egypt Recruiting

Study contacts

• Principal investigator: Sandy E Rezkallah, bachelor — Tanta University
• Study coordinator: Sandy Rezkallah, Bachelor
• Email: sandyehab58@gmail.com
• Phone: 01221065882

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.