Breast NeoplasmsSCARA-BNCT06443645
Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B
An observational study of Breast Neoplasms, run by Centre Paul Strauss at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Anthracycline
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The recruited population concerns adult patients followed for localized breast cancer and for whom treatment with anthracycline is indicated in the adjuvant or neoadjuvant situation.
Who may be able to join
- Patient > 18 years old
- Diagnosed with localized breast cancer
- Indication for first-line surgery or anthracycline-based chemotherapy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Paul Strauss
Strasbourg
Hervé BISCHOFF, MD, h.bischoff@institut-strauss.fr
promotion-rc@institut-strauss.fr
About this study
Official title: Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis - SCARA-B
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.
- Conditions
- Breast Neoplasms
- Being tested
- Anthracycline
- Keywords
- Breast cancer, Cardiotoxicities, SGLT2, Anthracyclines
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthracyclineDrug
as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant scheme | Indication for anthracycline-based chemotherapy after first-line surgery Receives: Drug: Anthracycline | |
| Neoadjuvant scheme | Indication for anthracycline-based chemotherapy Receives: Drug: Anthracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Secondary outcomes (2)
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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.
Measured: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
- Responsible party
- Sponsor
- Investigators
- Hervé BISCHOFF, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443645
- Sponsor's protocol ID
- 2023-024
- Acronym
- SCARA-B
- Status last verified
- Feb 2026
- First submitted
- 13 May 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis - SCARA-B
- ClinicalTrials.gov ID
- NCT06443645
- Acronym / sponsor ID
- SCARA-B / 2023-024
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Cardiotoxicities, SGLT2, Anthracyclines
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant scheme | – | Drug: AnthracyclineIndication for anthracycline-based chemotherapy after first-line surgery |
| Neoadjuvant scheme | – | Drug: AnthracyclineIndication for anthracycline-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruited population concerns adult patients followed for localized breast cancer and for whom treatment with anthracycline is indicated in the adjuvant or neoadjuvant situation.
Key inclusion criteria (3 listed)
- Patient > 18 years old
- Diagnosed with localized breast cancer
- Indication for first-line surgery or anthracycline-based chemotherapy.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthracyclineas standard of care | Drug | Adjuvant scheme, Neoadjuvant scheme |
Primary outcome
Evaluate the expression of SGLT2
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
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.
Evaluate the expression of SGLT2
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Measurement of the polarization of peripheral blood mononuclear cells (PBMCs) into pro-inflammatory M1 and anti-inflammatory M2 before and after epirubine infusion.
Evaluate the expression of SGLT2
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Fluorescence measurement of the level of reactive oxygen species (ROS) formation and senescence of cardiovascular cells before and after epirubine infusion.
Evaluate the expression of SGLT2
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Measurement of inflammatory mediators secreted by circulating cells.Comparison with positive and negative controls that induce inflammation and ROS before and after epirubine infusion.
2 secondary outcomes
Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment
Time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hervé BISCHOFF principal investigator
Centre Paul Strauss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne ANTHONY (+33(0)388252413, promotion-rc@institut-strauss.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the expression of SGLT2 (time frame: At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.