Breast CancerPhase 4SGLT2i/DPPiNCT07436663
Comparative Study Between (SGLT-2i) and (DPP-4i) in the Prevention of DIC
A Phase 4 study testing Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy and Sitagliptin (DPP4 inhibitor) in people with Breast Cancer, run by Tanta University at 1 site in Egypt.
Trial summary
Background: Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy and Sitagliptin (DPP4 inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Dec 2027
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female, ≥18 years, Egyptian nationality.
- Breast cancer (any stage) with planned anthracycline containing chemotherapy (intended cumulative DOX ≥240 mg/m² or epirubicin ≥360 mg/m² equivalents).
- Baseline echo suitable for LVEF ≥53%.
- Able to consent and comply with follow up.
Who cannot join
- • Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation.
- Symptomatic HF, cardiomyopathy, significant valvular disease, prior anthracycline exposure.
- Baseline hypotension (SBP <95 mmHg), recurrent UTIs/mycotic infections, active foot ulcer/critical limb ischemia.
- Inflammatory diseases, liver and kidney diseases.
- Autoimmune diseases.
- Other type of malignancies or metastatic diseases.
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- Patients who exposed to surgery less than one month.
- Concomitant dexrazoxane planned upfront (allowed only for rescue; documented).
- Known hypersensitivity to study drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Aboelyazed Elgebaly, Associate Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, Elgharbeya, GHR
Mai Aboelyazed El-Gebaly, Associate Lecturer, 010-6141-2257 ext. 020, dr.mai.elgebaly@gmail.com
Mai Aboelyazed Elgebaly, Associate Lecturer, 011-1506-4114 ext. 020, dr.mai.elgebaly@gmail.com
About this study
Official title: A Comparative Clinical Study Evaluating the Efficacy of (SGLT2)Inhibitors Versus (DPP-4) Inhibitors in the Prevention of Doxorubicin-Induced Cardiotoxicity Among Egyptian Women With Breast Cancer
Background:
Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure. The search for effective cardioprotective interventions is therefore a key priority in cardio-oncology.
Read more
Aim:
This study aims to compare the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer.
Methods:
A prospective, randomized, controlled clinical trial will be conducted at Oncology Hospital of Tanta University. Eligible adult female patients with histologically confirmed breast cancer scheduled to receive anthracycline-containing chemotherapy will be randomized into three groups: (1) control (standard care), (2) SGLT2 inhibitor group (dapagliflozin 10-25 mg daily), and (3) DPP-4 inhibitor group (sitagliptin 50-100 mg daily). Treatment will start five days before the first chemotherapy cycle and continue for six months, with follow-up for an additional six months. Cardiac function will be assessed by echocardiography (LVEF and GLS) and biomarkers (Cardiac Troponin T, and NT-proBNP). The primary endpoint is the incidence of cardiotoxicity defined by a ≥10% decline in LVEF to <50% or a >15% relative decline in GLS accompanied by biomarker elevation.
Expected Outcomes:
It is anticipated that both SGLT2 and DPP-4 inhibitors will reduce the incidence and severity of doxorubicin-induced cardiotoxicity, with SGLT2 inhibitors expected to demonstrate superior cardioprotective efficacy. Findings from this study may support the integration of cardioprotective antidiabetic agents into oncology care pathways to improve the cardiac outcomes and overall survival of breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy, Sitagliptin (DPP4 inhibitor), Standard Care (in control arm)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor TherapyDrug
Dapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months.
Sitagliptin (DPP4 inhibitor)Drug
Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months.
Standard Care (in control arm)Other
Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for).
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Control) | Placebo comparator | Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for). Receives: Other: Standard Care (in control arm) |
| Arm B (SGLT2i) | Active comparator | Dapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months. Receives: Drug: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy |
| Arm C (DPP 4i) | Active comparator | Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months. Receives: Drug: Sitagliptin (DPP4 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing cardiotoxicity
Cardiotoxicity will be defined as the occurrence of any of the following during the study period:
A decline in left ventricular ejection fraction (LVEF) ≥ 10% from baseline resulting in an LVEF < 50%, as measured by echocardiography, or
A relative reduction in global longitudinal strain (GLS) > 15% from baseline, as assessed by speckle-tracking echocardiography.
Unit of Measure: Percentage of participants experiencing cardiotoxicity (%)
Measured: Within 3 months from initiation of therapy.
Secondary outcomes (6)
Percentage Change in Left Ventricular Ejection Fraction (LVEF)
Description:
Absolute change in left ventricular ejection fraction from baseline to 3 months, measured by transthoracic echocardiography.
Unit of Measure: Percentage points (%)
Measured: 3 months
Percentage Change in Global Longitudinal Strain (GLS)
Description:
Relative percentage change in global longitudinal strain from baseline to 3 months, assessed using speckle-tracking echocardiography.
Unit of Measure: Percentage (%)
Measured: 6 months
Time to cardiotoxicity and HF hospitalization through 6 months.
Measured: 6 months
Change in serum cardiac biomarker levels e.g., troponin
Change in Cardiac Biomarkers (if applicable)
Description:
Change in serum cardiac biomarker levels (e.g., troponin) from baseline to 3 months.
Troponin: ng/L
Measured: 3 months
Change in serum cardiac biomarker levels (e.g., NT-proBNP)
Description:
Change in serum cardiac biomarker levels (e.g., NT-proBNP) from baseline to 3 months.
NT-proBNP: pg/mL
Measured: 3 months
All cause mortality and cancer therapy interruptions due to cardiac reasons.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, randomized, parallel controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Abo Elyazeed Hassan Hamouda, Delta University for Science and Technology
- Investigators
- Mohamed Abdelhamid Almeldein, Professor, Principal investigator, Tanta UniversityMohamed Elhussieny Shams, Professor, Principal investigator, Mansoura UniversityHaidy Mahmoud Sami, Lecturer, Study director, Delta UniversityOsama Hamid Shoaeb, Associate Professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436663
- Sponsor's protocol ID
- 2467Q8
- Acronym
- SGLT2i/DPPi
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study Evaluating the Efficacy of (SGLT2)Inhibitors Versus (DPP-4) Inhibitors in the Prevention of Doxorubicin-Induced Cardiotoxicity Among Egyptian Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07436663
- Acronym / sponsor ID
- SGLT2i/DPPi / 2467Q8
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
Background:
Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure. The search for effective cardioprotective interventions is therefore a key priority in cardio-oncology.
Aim:
This study aims to compare the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer.
Methods:
A prospective, randomized, controlled clinical trial will be conducted at Oncology Hospital of Tanta University. Eligible adult female patients with histologically confirmed breast cancer scheduled to receive anthracycline-containing chemotherapy will be randomized into three groups: (1) control (standard care), (2) SGLT2 inhibitor group (dapagliflozin 10-25 mg daily), and (3) DPP-4 inhibitor group (sitagliptin 50-100 mg daily). Treatment will start five days before the first chemotherapy cycle and continue for six months, with follow-up for an additional six months. Cardiac function will be assessed by echocardiography (LVEF and GLS) and biomarkers (Cardiac Troponin T, and NT-proBNP). The primary endpoint is the incidence of cardiotoxicity defined by a ≥10% decline in LVEF to <50% or a >15% relative decline in GLS accompanied by biomarker elevation.
Expected Outcomes:
It is anticipated that both SGLT2 and DPP-4 inhibitors will reduce the incidence and severity of doxorubicin-induced cardiotoxicity, with SGLT2 inhibitors expected to demonstrate superior cardioprotective efficacy. Findings from this study may support the integration of cardioprotective antidiabetic agents into oncology care pathways to improve the cardiac outcomes and overall survival of breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional, prospective, randomized, parallel controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm A (Control) | Placebo comparator | Other: Standard Care (in control arm)Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for). |
| Arm B (SGLT2i) | Active comparator | Drug: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor TherapyDapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months. |
| Arm C (DPP 4i) | Active comparator | Drug: Sitagliptin (DPP4 inhibitor)Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female, ≥18 years, Egyptian nationality.
- Breast cancer (any stage) with planned anthracycline containing chemotherapy (intended cumulative DOX ≥240 mg/m² or epirubicin ≥360 mg/m² equivalents).
- Baseline echo suitable for LVEF ≥53%.
- Able to consent and comply with follow up.
Key exclusion criteria (9 listed)
- • Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation.
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 |
|---|---|---|
| Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor TherapyDapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months. | Drug | Arm B (SGLT2i) |
| Sitagliptin (DPP4 inhibitor)Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months. | Drug | Arm C (DPP 4i) |
| Standard Care (in control arm)Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for). | Other | Arm A (Control) |
Primary outcome
Percentage of participants experiencing cardiotoxicity
Time frame: Within 3 months from initiation of therapy.
Cardiotoxicity will be defined as the occurrence of any of the following during the study period: A decline in left ventricular ejection fraction (LVEF) ≥ 10% from baseline resulting in an LVEF < 50%, as measured by echocardiography, or A relative reduction in global longitudinal strain (GLS) > 15% from baseline, as assessed by speckle-tracking echocardiography. Unit of Measure: Percentage of participants experiencing cardiotoxicity (%)
6 secondary outcomes
Percentage Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 3 months
Percentage Change in Global Longitudinal Strain (GLS)
Time frame: 6 months
Time to cardiotoxicity and HF hospitalization through 6 months.
Time frame: 6 months
Change in serum cardiac biomarker levels e.g., troponin
Time frame: 3 months
Change in serum cardiac biomarker levels (e.g., NT-proBNP)
Time frame: 3 months
All cause mortality and cancer therapy interruptions due to cardiac reasons.
Time frame: 6 months
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 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mai Aboelyazed Elgebaly, Associate Lecturer contact
Mohamed Abdelhamid Almeldein, Professor principal investigator
Tanta University
Mohamed Elhussieny Shams, Professor principal investigator
Mansoura University
Haidy Mahmoud Sami, Lecturer study director
Delta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy and Sitagliptin (DPP4 inhibitor) in people with Breast Cancer, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 9 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 15 Oct 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mai Aboelyazed Elgebaly, Associate Lecturer (+0201061412257 ext. 020, dr.mai.elgebaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants experiencing cardiotoxicity (time frame: Within 3 months from initiation of therapy.). 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 15 Oct 2026.