Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

NCT06427226 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Dapagliflozin in breast cancer
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.

Conditions

Doxorubicin Induced Cardiomyopathy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in ejection fraction using echocardiography

  Initial evaluation of cardiac function by Echocardiography at baseline and after the end of chemotherapy. The primary outcome is to avoid reduction in patients' ejection fraction during doxorubicin administration.

  Baseline and after the last AC cycle of chemotherapy (3months).

Secondary Outcomes (2)

• Change in Cardiac Troponin T level

  Baseline and after the last AC cycle of chemotherapy (3months).

• Change in N-terminal pro-B-type natriuretic peptide level

  Baseline and after the last AC cycle of chemotherapy (3months).

Study Arms (2)

Control Group

NO INTERVENTION

23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) only.

Dapagliflozin group

ACTIVE COMPARATOR

23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) plus Dapagliflozin 10 mg once daily.

Drug: Dapagliflozin 10mg Tab

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10 mg tab once daily given during the duration of AC cycles.

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Medical Research Institute

Alexandria, Bab Sharqi, 21526, Egypt

RECRUITING

Related Publications (3)

• Belen E, Canbolat IP, Yigitturk G, Cetinarslan O, Akdeniz CS, Karaca M, Sonmez M, Erbas O. Cardio-protective effect of dapagliflozin against doxorubicin induced cardiomyopathy in rats. Eur Rev Med Pharmacol Sci. 2022 Jun;26(12):4403-4408. doi: 10.26355/eurrev_202206_29079.

  PMID: 35776041 BACKGROUND

• Avula V, Sharma G, Kosiborod MN, Vaduganathan M, Neilan TG, Lopez T, Dent S, Baldassarre L, Scherrer-Crosbie M, Barac A, Liu J, Deswal A, Khadke S, Yang EH, Ky B, Lenihan D, Nohria A, Dani SS, Ganatra S. SGLT2 Inhibitor Use and Risk of Clinical Events in Patients With Cancer Therapy-Related Cardiac Dysfunction. JACC Heart Fail. 2024 Jan;12(1):67-78. doi: 10.1016/j.jchf.2023.08.026. Epub 2023 Oct 25.

  PMID: 37897456 BACKGROUND

• Chang WT, Lin YW, Ho CH, Chen ZC, Liu PY, Shih JY. Dapagliflozin suppresses ER stress and protects doxorubicin-induced cardiotoxicity in breast cancer patients. Arch Toxicol. 2021 Feb;95(2):659-671. doi: 10.1007/s00204-020-02951-8. Epub 2020 Nov 19.

  PMID: 33211168 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandy E Rezkallah, bachelor

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Rezkallah, Bachelor

CONTACT

01221065882; sandyehab58@gmail.com

Osama M Ibrahim, Professor

CONTACT

osama.mohamed.ibrahim@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 23, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

EG (1)