Clinical trial · Interventional
Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity
Study Phase II "Proof of Concept", National Multi-centered. Randomised 1:1, Evaluate Whether Dapagliflozin Reduces Chemotherapy Induced Cardiotoxicity in Participants With Breast Cancer Treated With (Neo-) Adjuvant Anthracycline-based Chemotherapy +/- Trastuzumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active group - Dapagliflozin 10 mg
- interventionNames
- Drug: Dapagliflozin 10mg Tab
- type
- NO_INTERVENTION
- label
- Control group - Standard of care
Primary outcomes (1)
- measure
- Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up.
- timeFrame
- baseline, 3 months, 6 months, 12 months and 18 months.
- description
- Change of Left Ventricular Ejection Fraction Global Longitudinal Strain at 3-6-12 and 18 months compared with baseline will be measured using transthoracic echocardiography.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Chemotherapy-naive patients, scheduled for antracycline +/- trastuzumab treatment in the (neo-)adjuvant setting for stage I-III breast cancer. * Adult women between 18 and 70 years of age * eGFR\>25 ml/min/1.7 mq * ECOG score 0-2Consent form signed. Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative result from a serum pregnancy test performed within 7 days of randomization and on the day of first study treatment prior to the initiation of study treatment. Women of childbearing potential must agree to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug. Women of childbearing potential willing to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug . Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \<53%\* * Valvular heart disease. * Previous malignancy requiring treatment with anthracyclines or chest radiotherapy. * A life expectancy of ≤12 weeks. * Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method. * Currently breast-feeding women * History of hypersensitivity to dapagliflozin or any of the excipients of the product. * History of Diabetic Ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to enrolment visit. * Type 1 diabetes mellitus
References
Publications (1)
- DERIVEDGreco A, Quagliariello V, Rizzo G, Tedeschi A, Schirinzi S, Turco A, Galiazzo M, Acquaro M, De Amicis M, Klersy C, Ghio S, Perrone L, Paccone A, Uccello G, Canale ML, Oliva S, Guerra F, De Luca L, Maurea N, Scelsi L. SGLT2i Dapagliflozin in primary prevention of chemotherapy induced cardiotoxicity in breast cancer patients treated with neo-adjuvant anthracycline-based chemotherapy +/- trastuzumab: rationale and design of the multicenter PROTECT trial. Cardiooncology. 2025 Sep 1;11(1):79. doi: 10.1186/s40959-025-00368-9. PMID 40890873