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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06443645
Other study ID # 2023-024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date April 4, 2026

Study information

Verified date May 2024
Source Institut de cancérologie Strasbourg Europe
Contact Simon NANNINI
Phone +33368767360
Email s.nannini@icans.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 4, 2026
Est. primary completion date May 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anthracycline
as standard of care

Locations

Country Name City State
France Institut de cancérologie Strasbourg Europe Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the expression of SGLT2 Measurement of protein expression (Western Blot) and mRNA (RT-qPCR) of SGLT2 within the different models studied and according to the cumulative quantity of anthracyclines received and the patient's cardiovascular history before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Primary Evaluate the expression of SGLT2 Measurement of the polarization of peripheral blood mononuclear cells (PBMCs) into pro-inflammatory M1 and anti-inflammatory M2 before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Primary Evaluate the expression of SGLT2 Fluorescence measurement of the level of reactive oxygen species (ROS) formation and senescence of cardiovascular cells before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Primary Evaluate the expression of SGLT2 Measurement of inflammatory mediators secreted by circulating cells.Comparison with positive and negative controls that induce inflammation and ROS before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Secondary Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment Measurement of the antiplatelet activity of endothelial celles (ECs) mediated by nitric oxide (NO), the procoagulant activity and the adhesion of platelets and monocytes to ECs before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Secondary Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment Quantification of inflammatory mediators in plasma and produced by treated cardiovascular cells before and after epirubine infusion. At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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