NCT06443645 Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B
| NCT ID | NCT06443645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Paul Strauss |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-02-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the context of breast cancer, in case of an indication for chemotherapy, anthracycline-based protocols make it possible to improve the overall survival of patients most at risk. The frequency of anthracycline-related cardiac toxicities (ARCT) increases with the cumulative dose of anthracyclines administered and explains, at least in part, the increased risk of cardiovascular (CV) mortality in patient populations treated for breast cancer. The numerous indications for anthracycline-based protocols have made it possible to describe ARCT, among which heart failure with reduced left ventricular ejection fraction (LVEF) remains one of the most comorbid. In addition to left ventricular dysfunction, anthracyclines have been associated with endothelial dysfunction, microvascular damage and myocardial ischemia responsible for dilated cardiomyopathy. Different approaches have attempted to better understand and prevent these ARCT. However, apart from the notion of limit cumulative doses of anthracyclines, few of them have made it possible to screen patients at risk and prevent the onset of cardiac dysfunction. The search for biological markers (Troponin I, BNP) or ultrasound markers (Longitudinal Strain) warning of subclinical cardiac damage is still struggling to assert its interest due in particular to significant inter- and intra-observer variability. Therapeutically, ACE inhibitors and beta-blockers have shown a significant improvement in the incidence rate of LVEF reduction during adjuvant treatment of breast cancer. However, despite equivalent signals in other cancers, the studies conducted to date are insufficiently powered and the role of these treatments is limited to secondary prevention or the treatment of objective heart failure. It remains necessary to determine new biological markers that can identify patients most at risk of ARCT and thus adapt our therapeutic prevention strategies. To do this, it is first necessary to better understand the pathophysiology underlying these ARCT. The objective of this study is to determine whether expression of the receptor among endothelium and circulating cells, SGLT2, is associated with an additional risk of presenting cardiovascular toxicity following treatment with anthracycline. If this association is demonstrated, it will then be possible to better screen and prevent these cardiovascular complications.
Eligibility Criteria
Inclusion Criteria: * Patient \> 18 years old * Diagnosed with localized breast cancer * Indication for first-line surgery or anthracycline-based chemotherapy. Exclusion Criteria: * History of chemotherapy or targeted therapy or immunotherapy administered before inclusion * Patient currently being treated with anti-SGLT2, conversion enzyme inhibitor or ARA2 * Patient with known heart disease (ischemic, rhythmic, valvular, etc.) * Patient with a Glomerular filtration rate \< 45 mL/min/1.73m² according to the pre-therapeutic assessment * Patient with impaired liver function * Patient who is pregnant or breastfeeding * Patient with a second cancer undergoing treatment * Patient under guardianship or curatorship, protection of justice or deprived of liberty
Contact & Investigator
Hervé BISCHOFF
PRINCIPAL INVESTIGATOR
Centre Paul Strauss
Frequently Asked Questions
Who can join the NCT06443645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06443645 currently recruiting?
Yes, NCT06443645 is actively recruiting participants. Contact the research team at promotion-rc@institut-strauss.fr for enrollment information.
Where is the NCT06443645 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT06443645 clinical trial?
NCT06443645 is sponsored by Centre Paul Strauss. The principal investigator is Hervé BISCHOFF at Centre Paul Strauss. The trial plans to enroll 50 participants.