Cardioprotective Effect of Empagliflozin in Breast Cancer Patients

Sponsor
Tanta University
Study ID
NCT07815808
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Empgliflozin Cardioprotective Effect

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (EMPA) — DRUG
    Intervention group: A group in which patients receive Empagliflozin drug at a dose of 10 mg once in the day, or along with chemotherapy.
  • Metformin — DRUG
    Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) Initiated 1 week prior to chemotherapy; continued for 12 weeks

Study Details

Background: Doxorubicin (DOX) remains a cornerstone in adjuvant and neoadjuvant therapy for breast cancer, but its utility is hindered by dose-dependent cardiotoxicity. Both SGLT2 inhibitors (Empagliflozin) and Biguanides (Metformin) have demonstrated off-target cardioprotective and metabolic properties in preclinical and clinical settings. Objective: To compare the cardioprotective efficacy, safety, and metabolic/oncologic outcomes of Empagliflozin versus Metformin in non-diabetic or controlled-diabetic women with breast cancer undergoing doxorubicin-based chemotherapy. Design: Prospective, 3-arm, open-label (or double-blind), randomized controlled clinical trial (RCT). Duration: 18 months

Key Dates

First listed
Sep 11, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Arm A (Control)
    Standard oncologic care without cardioprotective intervention followed concurrently for 12 weeks
  • Active Comparator: Arm B (Empaglflozin)
    Empagliflozin 10 mg orally once daily initiated 1 week prior to chemotherapy; continued for 12 weeks
  • Active Comparator: Arm C (Metformin)
    Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) initiated 1 week prior to chemotherapy; continued for 12 weeks

Primary Outcome Measure

LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction. [ Time Frame: 6 months ]

Central Contacts