Investigating the effects of SGLT2 inhibitors on heart issues from breast cancer treatment
Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis - SCARA-B
This study is testing if a diabetes medication can help protect the hearts of women with localized breast cancer who are receiving certain chemotherapy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06443645 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with localized breast cancer who are indicated for anthracycline-based chemotherapy. It aims to understand the role of Sodium-glucose Linked Transporter 2 (SGLT2) inhibitors in mitigating cardiac toxicities associated with anthracycline treatment. The study will assess the frequency and severity of anthracycline-related cardiac toxicities, including heart failure and other cardiovascular complications, in this patient population. By analyzing these effects, the study seeks to provide insights into potential protective strategies against cardiotoxicity during breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with localized breast cancer who are scheduled for first-line surgery or anthracycline-based chemotherapy.
Not a fit: Patients with a history of heart disease, those currently on anti-SGLT2 medications, or those with significantly impaired kidney or liver function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac health and overall survival for breast cancer patients undergoing anthracycline chemotherapy.
How similar studies have performed: While various approaches have been explored to address anthracycline-related cardiac toxicities, the specific role of SGLT2 inhibitors in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg
- Centre Paul Strauss — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Hervé BISCHOFF — Centre Paul Strauss
- Study coordinator: Anne ANTHONY
- Email: promotion-rc@institut-strauss.fr
- Phone: +33(0)388252413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.