Cardiotoxicity in Breast Cancer Patients

NCT06491680 | Recruiting Phase 4

• 1 other identifier: Dapagliflozin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug. Aim of the study: Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity. The main questions it aims to answer are:

1. 1.Does the drug lower the cardiotoxicity which induced by anthracyclines?
2. 2.What medical problems do participants have when taking dapagliflozin drug?
3. 3.Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination.
4. 4.Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing

  Monitoring the serum at Baseline and after the last cycle of anthracyclines. Changes in serum NT-Pro BNP from baseline will be calculated and compared between groups

  Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months from baseline)

Secondary Outcomes (1)

• Echocardiography by measuring left ventricular ejection fraction (LVEF)

  a) Baseline b) After the last cycle of anthracyclines (approximately 2 to 3 months from baseline) c) 3 months after the end of chemotherapy (approximately 5 to 6 months from baseline) d) As needed for any symptomatic patients

Study Arms (2)

Dapagliflozin group

ACTIVE COMPARATOR

Dapagliflozin group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) with dapagliflozin 10 mg tablet once daily.

Drug: Dapagliflozin 10mg Tab

Control group

NO INTERVENTION

Control group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) only.

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose. taken orally, once daily. Started from 5 to 7 days before the first cycle of anthracyclines till the end of last anthracycline dose.

Also known as: Dapablix 10 mg

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with pathologically proved invasive breast carcinoma.
• Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
• Renal function (eGFR \> 30 mL/minute per 1.73 m2 )
• LVEF is more than 50 %
• Age ≥ 18 and ≤ 60 years old

You may not qualify if:

• patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
• Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
• pregnant or breastfeeding patients
• patients receiving any other cardiotoxic agents.
• Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
• Mediastinal irradiation including heart.
• Refusal to sign the written informed consent.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Al demerdash hospital at oncology departement

Cairo, Cairo Governorate, 202, Egypt

RECRUITING

Related Links

• Dempke, Wolfram CM, et al. "Anthracycline-induced cardiotoxicity-are we about to clear this hurdle?." European Journal of Cancer 185 (2023): 94-104.
• Hwang, Hui-Jeong, et al. "Sodium-glucose cotransporter-2 inhibitors improve clinical outcomes in patients with type 2 diabetes mellitus undergoing anthracycline-containing chemotherapy: an emulated target trial.
• Kuo, Hsiao-Huai, et al. "Cardiovascular outcomes associated with SGLT2 inhibitor therapy in patients with type 2 diabetes mellitus and cancer: a systematic review and meta-analysis." Diabetology \& Metabolic Syndrome 16.1 (2024): 108.
• Henriksen, P, Rankin, S, Lang, N. Cardioprotection in Patients at High Risk of Anthracycline-Induced Cardiotoxicity: JACC: CardioOncology Primer. J Am Coll Cardiol CardioOnc. 2023 Jun, 5 (3) 292-297.
• Dabour, Mohamed S., et al. "The Cardioprotective and Anticancer Effects of SGLT2 Inhibitors: JACC: CardioOncology State-of-the-Art Review." Cardio Oncology 6.2 (2024): 159-182.
• Avagimyan, Ashot, et al. "Possibilities of dapagliflozin-induced cardioprotection on doxorubicin+ cyclophosphamide mode of chemotherapy-induced cardiomyopathy." International Journal of Cardiology 391 (2023): 131331.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shimaa Nabil Abd elaziz Hassanein, bachelor

CONTACT

+201115817090; Shimaa.Nabil@pharm.helwan.edu.eg

Sara Mohamed Mohamed, Lecturer

CONTACT

+201016903404; Sara.abdel-motaleb@pharm.helwan.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy - Pharmacy Practice Department, Faculty of Pharmacy - Helwan University

Model Details: it is a randomized controlled trial for at least 40 breast cancer patients who receive 4 cycles of anthracyclines. These patients are divided into 2 groups . Group 1 take anthracyclines with dapagliflozin 10 mg and group 2 take anthracyclines only.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: September 10, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)