Breast CancerPhase 1/2NCT07370506
Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients
A Phase 1/2 study testing Telmisartan and Doxorubicin (DOX) in people with Breast Cancer and Doxorubicin Induced Cardiomyopathy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy and safety of telmisartan as a cardioprotective agent in patients receiving doxorubicin-based chemotherapy, with the goal of reducing treatment-associated cardiotoxicity, optimizing therapeutic outcomes, and facilitating the safer administration of anthracycline regimens. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- What is being tested?
- Telmisartan and Doxorubicin (DOX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Feb 2027
- Phase
- Phase 1/2
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with breast cancer.
- Age ≥18 \& ≤ 65 years.
- Newly diagnosed, chemotherapy-naïve patients.
- Baseline echocardiogram showing left ventricular ejection fraction (LVEF) ≥55%.
Who cannot join
- Presence of hypersensitivity to telmisartan.
- History of cardiovascular disease (e.g., congestive heart failure, ischemic heart disease, arrhythmia).
- Patients with any chronic liver or renal dysfunction; inflammatory diseases; autoimmune disease; acute cardiovascular events, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Baseline blood pressure ≥ 160/100 mmHg
- Current or prior use of ARBs/ACE inhibitors
- Current participation in another clinical trial within the past 30 days.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Telmisartan in Preventing Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
This study aims to evaluate the efficacy and safety of telmisartan as a cardioprotective agent in patients receiving doxorubicin-based chemotherapy, with the goal of reducing treatment-associated cardiotoxicity, optimizing therapeutic outcomes, and facilitating the safer administration of anthracycline regimens.
Read the detailed description
Doxorubicin remains one of the most effective chemotherapeutic agents for the treatment of a wide range of solid tumors and hematological malignancies. However, its clinical use is limited by dose-dependent cardiotoxicity, which may manifest as subclinical myocardial injury, left ventricular dysfunction, and progression to heart failure. The mechanisms underlying doxorubicin-induced cardiotoxicity are multifactorial, with oxidative stress recognized as a central pathway contributing to reactive oxygen species (ROS) generation, mitochondrial dysfunction, and cardiomyocyte injury. These effects highlight the need for strategies to reduce cardiovascular complications associated with doxorubicin therapy without compromising anticancer efficacy.
Telmisartan, an angiotensin II type 1 receptor blocker (ARB), has demonstrated pharmacological effects beyond blood pressure control. Preclinical studies suggest that telmisartan may reduce oxidative stress, improve endothelial function, and preserve mitochondrial integrity, partly through modulation of peroxisome proliferator-activated receptor gamma (PPAR-γ) pathways. These effects may contribute to attenuation of cardiac remodeling and myocardial injury. Despite these observations, clinical evidence evaluating telmisartan for the prevention of doxorubicin-induced cardiotoxicity remains limited and inconclusive. Recent in vitro findings also indicate that telmisartan may enhance doxorubicin-induced apoptosis and cytotoxic efficacy in cancer cell lines. These findings raise the possibility that telmisartan could exert both cardioprotective and chemosensitizing effects.
Considering this evidence gap, the present study is designed to investigate the cardioprotective role of telmisartan in patients undergoing doxorubicin-based chemotherapy.
- Conditions
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- Being tested
- Telmisartan, Doxorubicin (DOX)
- Keywords
- Telmisartan, Anthracycline Cardiotoxicity, Troponin, NT-proBNP, Cardioprotection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Telmisartan administered orally once daily as cardioprotective therapy during doxorubicin-based chemotherapy.
Doxorubicin (DOX)Drug
Standard doxorubicin-based chemotherapy according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan Group | Experimental | Participants receiving telmisartan in addition to standard doxorubicin-based chemotherapy. Receives: Drug: Telmisartan; Drug: Doxorubicin (DOX) |
| Control Group | Active comparator | Participants receiving standard doxorubicin-based chemotherapy without telmisartan. Receives: Drug: Doxorubicin (DOX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
The primary outcome is the absolute change in left ventricular ejection fraction (LVEF) from baseline to the end of doxorubicin-based chemotherapy, assessed by echocardiography.
Measured: Baseline to end of chemotherapy (approximately 12-18 weeks)
Secondary outcomes (2)
Change in High-Sensitivity Cardiac Troponin T (hs-cTnT) Levels
Measurement of serum hs-cTnT at baseline and at the end of doxorubicin-based chemotherapy to assess myocardial injury and cardiac stress in patients receiving telmisartan or standard care.
Measured: Baseline (pre-chemotherapy) to end of chemotherapy (approximately 12-18 weeks)
Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Levels
Measurement of serum NT-proBNP at baseline and at the end of doxorubicin-based chemotherapy. Any increase from baseline indicates early ventricular strain or subclinical heart failure in patients receiving telmisartan or standard care.
Measured: Baseline to end of chemotherapy (approximately 12-18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatullah Galal Ahmed Barakat, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370506
- Sponsor's protocol ID
- 2467R4
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seino Y, Takahashi H, Fukumoto H, Utsumi K, Hirai Y. Cardiovascular manifestations of Fabry disease and the novel therapeutic strategies. J Nippon Med Sch. 2005 Oct;72(5):254-61. doi: 10.1272/jnms.72.254.
PubMed 16247224Taniguchi N. From the gamma-glutamyl cycle to the glycan cycle: a road with many turns and pleasant surprises. J Biol Chem. 2009 Dec 11;284(50):34469-78. doi: 10.1074/jbc.X109.023150. Epub 2009 Oct 19. No abstract available.
PubMed 19840938Arciuli J, Simpson IC. Statistical learning is lasting and consistent over time. Neurosci Lett. 2012 May 31;517(2):133-5. doi: 10.1016/j.neulet.2012.04.045. Epub 2012 Apr 25.
PubMed 22561650Simeunovic B, Strbenc M, Bavdek SV. Position and histological structure of the testes in the brown hare (Lepus europaeus) during seasonal regression and recrudescence. Anat Histol Embryol. 2000 Apr;29(2):73-82. doi: 10.1046/j.1439-0264.2000.00233.x.
PubMed 10932383Banegas JR, Segura J, Ruilope LM, Luque M, Garcia-Robles R, Campo C, Rodriguez-Artalejo F, Tamargo J; CLUE Study Group Investigators. Blood pressure control and physician management of hypertension in hospital hypertension units in Spain. Hypertension. 2004 Jun;43(6):1338-44. doi: 10.1161/01.HYP.0000127424.59774.84. Epub 2004 Apr 26.
PubMed 15117908
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telmisartan in Preventing Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07370506
- Acronym / sponsor ID
- 2467R4
- Conditions
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- Keywords
- Telmisartan, Anthracycline Cardiotoxicity, Troponin, NT-proBNP, Cardioprotection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Jan 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.
This study aims to evaluate the efficacy and safety of telmisartan as a cardioprotective agent in patients receiving doxorubicin-based chemotherapy, with the goal of reducing treatment-associated cardiotoxicity, optimizing therapeutic outcomes, and facilitating the safer administration of anthracycline regimens.
Detailed description
Doxorubicin remains one of the most effective chemotherapeutic agents for the treatment of a wide range of solid tumors and hematological malignancies. However, its clinical use is limited by dose-dependent cardiotoxicity, which may manifest as subclinical myocardial injury, left ventricular dysfunction, and progression to heart failure. The mechanisms underlying doxorubicin-induced cardiotoxicity are multifactorial, with oxidative stress recognized as a central pathway contributing to reactive oxygen species (ROS) generation, mitochondrial dysfunction, and cardiomyocyte injury. These effects highlight the need for strategies to reduce cardiovascular complications associated with doxorubicin therapy without compromising anticancer efficacy.
Telmisartan, an angiotensin II type 1 receptor blocker (ARB), has demonstrated pharmacological effects beyond blood pressure control. Preclinical studies suggest that telmisartan may reduce oxidative stress, improve endothelial function, and preserve mitochondrial integrity, partly through modulation of peroxisome proliferator-activated receptor gamma (PPAR-γ) pathways. These effects may contribute to attenuation of cardiac remodeling and myocardial injury. Despite these observations, clinical evidence evaluating telmisartan for the prevention of doxorubicin-induced cardiotoxicity remains limited and inconclusive. Recent in vitro findings also indicate that telmisartan may enhance doxorubicin-induced apoptosis and cytotoxic efficacy in cancer cell lines. These findings raise the possibility that telmisartan could exert both cardioprotective and chemosensitizing effects.
Considering this evidence gap, the present study is designed to investigate the cardioprotective role of telmisartan in patients undergoing doxorubicin-based chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan Group | Experimental | Drug: Telmisartan, Drug: Doxorubicin (DOX)Participants receiving telmisartan in addition to standard doxorubicin-based chemotherapy. |
| Control Group | Active comparator | Drug: Doxorubicin (DOX)Participants receiving standard doxorubicin-based chemotherapy without telmisartan. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients with breast cancer.
- Age ≥18 \& ≤ 65 years.
- Newly diagnosed, chemotherapy-naïve patients.
- Baseline echocardiogram showing left ventricular ejection fraction (LVEF) ≥55%.
Key exclusion criteria (7 listed)
- Presence of hypersensitivity to telmisartan.
- History of cardiovascular disease (e.g., congestive heart failure, ischemic heart disease, arrhythmia).
- Patients with any chronic liver or renal dysfunction; inflammatory diseases; autoimmune disease; acute cardiovascular events, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Baseline blood pressure ≥ 160/100 mmHg
- Current or prior use of ARBs/ACE inhibitors
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 |
|---|---|---|
| TelmisartanTelmisartan administered orally once daily as cardioprotective therapy during doxorubicin-based chemotherapy. | Drug | Telmisartan Group |
| Doxorubicin (DOX)Standard doxorubicin-based chemotherapy according to institutional protocol. | Drug | Control Group, Telmisartan Group |
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline to end of chemotherapy (approximately 12-18 weeks)
The primary outcome is the absolute change in left ventricular ejection fraction (LVEF) from baseline to the end of doxorubicin-based chemotherapy, assessed by echocardiography.
2 secondary outcomes
Change in High-Sensitivity Cardiac Troponin T (hs-cTnT) Levels
Time frame: Baseline (pre-chemotherapy) to end of chemotherapy (approximately 12-18 weeks)
Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Levels
Time frame: Baseline to end of chemotherapy (approximately 12-18 weeks)
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 29 Jan 2026.
- Background: PubMed 16247224Seino Y, Takahashi H, Fukumoto H, Utsumi K, Hirai Y. Cardiovascular manifestations of Fabry disease and the novel therapeutic strategies. J Nippon Med Sch. 2005 Oct;72(5):254-61. doi: 10.1272/jnms.72.254.
- Background: PubMed 19840938Taniguchi N. From the gamma-glutamyl cycle to the glycan cycle: a road with many turns and pleasant surprises. J Biol Chem. 2009 Dec 11;284(50):34469-78. doi: 10.1074/jbc.X109.023150. Epub 2009 Oct 19. No abstract available.
- Background: PubMed 22561650Arciuli J, Simpson IC. Statistical learning is lasting and consistent over time. Neurosci Lett. 2012 May 31;517(2):133-5. doi: 10.1016/j.neulet.2012.04.045. Epub 2012 Apr 25.
- Background: PubMed 10932383Simeunovic B, Strbenc M, Bavdek SV. Position and histological structure of the testes in the brown hare (Lepus europaeus) during seasonal regression and recrudescence. Anat Histol Embryol. 2000 Apr;29(2):73-82. doi: 10.1046/j.1439-0264.2000.00233.x.
- Background: PubMed 15117908Banegas JR, Segura J, Ruilope LM, Luque M, Garcia-Robles R, Campo C, Rodriguez-Artalejo F, Tamargo J; CLUE Study Group Investigators. Blood pressure control and physician management of hypertension in hospital hypertension units in Spain. Hypertension. 2004 Jun;43(6):1338-44. doi: 10.1161/01.HYP.0000127424.59774.84. Epub 2004 Apr 26.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Telmisartan and Doxorubicin (DOX) in people with Breast Cancer and Doxorubicin Induced Cardiomyopathy, 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 7 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: opening soon, as of the sponsor's last update on 29 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Menna Ahmed (+20 1000854864, mennagalal822@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline to end of chemotherapy (approximately 12-18 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370506, which also lists 5 linked publications.
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 29 Jan 2026.