Anthracycline-induced Cardiac ToxicityPhase 4ROSUBREASTNCT07254221
Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients
A Phase 4 study testing Rosuvastatin 20 mg/day in people with Anthracycline-induced Cardiac Toxicity and Breast Cancer, run by Shiraz University of Medical Sciences at 7 sites in Iran.
Trial summary
This study, called "ROSUBREAST", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer
- What is being tested?
- Rosuvastatin 20 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 7 sitesIran
- Study dates
- 1 Feb 2026to 21 Apr 2028
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female individuals with ≥18 years of age
- Documented breast cancer diagnosis based on imaging and pathology findings
- Scheduled to receive the first time anthracycline-based chemotherapy
Who cannot join
- Baseline LVEF < 50%
- Prior Statin use or Statin use is indicated based on guidelines
- history of congestive heart failure (CHF) or cardiomyopathy
- Pregnancy or breastfeeding
- Unable to provide informed consent
- Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
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- Concomitant use of oral cyclosporine
- Metastatic invasion of cancer to other organs
- Previous cycles of chemotherapy
- Any contraindication for statin use
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Iran7 sites
Toba Oncology Department, Mazandaran University of Medical Sciences
Sari, Mazandaran
Maryam Nabati, +98 11 3304 4000, dr.mr.nabati@gmail.com
Motahari Breast Cancer Clinic
Shiraz, Fars, 71344-1864
Armin Attar, Associate Professor, attar_armin@yahoo.com
Kowsar Hospital, Fars Heart Foundation
Shiraz, Fars
Masoud Sayad, +98 71 3614 1000, masoud.sayad@yahoo.com
Modarres Hospital, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province
Shabnam Kazemloo, +98 21 23515, kazemloo.shabnam@sbmu.ac.ir
Rajaee Hospital, Iran University of Medical Sciences
Tehran, Tehran Province
Azin Alizadehasl, +98 21 3455 2001, alizadeasl@gmail.com
Sina Hospital, Tehran University of Medical Sciences
Tehran, Tehran Province
Zahra Shajari, +98 21 6634 8587, adz.shajari@gmail.com
Taleghani Hospital, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province
Alireza Farzaei, +98 21 2243 2566, alirezafarzaei@gmail.com
About this study
Official title: Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy
This study, called "ROSUBREAST", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. A total of 400 participants will be randomly assigned to receive either rosuvastatin or placebo for 12 months. The main goal is to determine whether rosuvastatin can prevent cancer treatment-related cardiac dysfunction (CTRCD), defined as a significant drop in heart pumping function. The study will also assess changes in cardiac strain, blood biomarkers, symptoms of heart failure, quality of life, and possible side effects.
Read the detailed description
Introduction: Anthracycline-induced cardiotoxicity significantly threatens the long-term cardiac health of breast cancer patients undergoing chemotherapy. Statins have shown potential cardioprotective effects without compromising cancer treatment efficacy. The ROSUBREAST study aims to evaluate the efficacy of rosuvastatin in preventing CTRCD in breast cancer patients receiving anthracycline-based chemotherapy. Methods: This multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo controlled clinical trial will be conducted across seven oncocardiology centers in Iran. A total of 400 participants will be enrolled and will be randomly assigned in a 1:1 ratio to receive either rosuvastatin (20 mg daily) or no intervention for 12 months. The primary endpoint is the incidence of CTRCD, defined as a ≥10% reduction in left ventricular ejection fraction (LVEF) to below the lower normal limit (53%). Secondary endpoints include changes in Global Longitudinal Strain (GLS), biomarkers (Troponin, NT-proBNP, hsCRP), and development of heart failure (HF). Ancillary endpoints are quality-of-life assessments and adverse effects of treatment. Conclusion: The ROSUBREAST study seeks to provide evidence on the cardioprotective role of rosuvastatin in breast cancer patients undergoing anthracycline-based chemotherapy, potentially informing clinical guidelines and improving patient outcomes.
- Conditions
- Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Anthracycline-induced Cardiotoxicity
- Being tested
- Rosuvastatin 20 mg/day, Placebo tablets similar to rosuvastatin 20mg tablets
- Keywords
- Breast cancer, rosuvastatin, statin therapy,, cancer-related treatment cardiac dysfunction, anthracycline induced cardiomyopathy, cardiac dysfunction, cardiotoxicity, chemotherapy, anthracycline
- 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.
Rosuvastatin 20 mg/dayDrug
Consumption of rosuvastatin 20mg tablets every day
Placebo tablets similar to rosuvastatin 20mg tabletsDrug
consumption of placebo tablets similar to rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Consumption of 20 milligrams rosuvastatin daily Receives: Drug: Rosuvastatin 20 mg/day |
| Placebo | Placebo comparator | Placebo (placebo tablets similar to rosuvastatin) Receives: Drug: Placebo tablets similar to rosuvastatin 20mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTRCD (cancer treatment-related cardiac dysfunction)
CTRCD is defined as a reduction of ≥10 percentage points in LVEF by echocardiography to <53% or a >15% relative decline in global longitudinal strain (GLS) compared with baseline strain.
Measured: 12 months after randomization
Secondary outcomes (5)
changes in LVEF
Measured: 3, 6, and 12 months after randomization
changes in Global Longitudinal Strain (GLS)
Measured: 3, 6, and 12 months after randomization
changes in Troponin level
Measured: 3, 6, and 12 months after randomization
changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level
Measured: 3, 6, and 12 months after randomization
changes in High-sensitivity C-reactive Protein (hsCRP) level
Measured: 3, 6, and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Feb 2026 (estimated)
- Primary completion21 Apr 2028 (estimated)
- Study completion21 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anthracycline-induced Cardiac ToxicityStudies 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
- multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Attar, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254221
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1404.351
- Other IDs
- IRCT20191002044961N2
- Acronym
- ROSUBREAST
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD used in the main analyses of CSR will be shared upon reasonable request from the principal investigator and confirmation by trial management committee (TMC).
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy
- ClinicalTrials.gov ID
- NCT07254221
- Acronym / sponsor ID
- ROSUBREAST / IR.SUMS.MED.REC.1404.351
- Conditions
- Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Anthracycline-induced Cardiotoxicity
- Keywords
- Breast cancer, rosuvastatin, statin therapy,, cancer-related treatment cardiac dysfunction, anthracycline induced cardiomyopathy, cardiac dysfunction, cardiotoxicity, chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 21 Apr 2028 (estimated)
- Study completion
- 21 Apr 2028 (estimated)
- First posted
- 28 Nov 2025 (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, called "ROSUBREAST", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. A total of 400 participants will be randomly assigned to receive either rosuvastatin or placebo for 12 months. The main goal is to determine whether rosuvastatin can prevent cancer treatment-related cardiac dysfunction (CTRCD), defined as a significant drop in heart pumping function. The study will also assess changes in cardiac strain, blood biomarkers, symptoms of heart failure, quality of life, and possible side effects.
Detailed description
Introduction: Anthracycline-induced cardiotoxicity significantly threatens the long-term cardiac health of breast cancer patients undergoing chemotherapy. Statins have shown potential cardioprotective effects without compromising cancer treatment efficacy. The ROSUBREAST study aims to evaluate the efficacy of rosuvastatin in preventing CTRCD in breast cancer patients receiving anthracycline-based chemotherapy. Methods: This multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo controlled clinical trial will be conducted across seven oncocardiology centers in Iran. A total of 400 participants will be enrolled and will be randomly assigned in a 1:1 ratio to receive either rosuvastatin (20 mg daily) or no intervention for 12 months. The primary endpoint is the incidence of CTRCD, defined as a ≥10% reduction in left ventricular ejection fraction (LVEF) to below the lower normal limit (53%). Secondary endpoints include changes in Global Longitudinal Strain (GLS), biomarkers (Troponin, NT-proBNP, hsCRP), and development of heart failure (HF). Ancillary endpoints are quality-of-life assessments and adverse effects of treatment. Conclusion: The ROSUBREAST study seeks to provide evidence on the cardioprotective role of rosuvastatin in breast cancer patients undergoing anthracycline-based chemotherapy, potentially informing clinical guidelines and improving patient outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Rosuvastatin 20 mg/dayConsumption of 20 milligrams rosuvastatin daily |
| Placebo | Placebo comparator | Drug: Placebo tablets similar to rosuvastatin 20mg tabletsPlacebo (placebo tablets similar to rosuvastatin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female individuals with ≥18 years of age
- Documented breast cancer diagnosis based on imaging and pathology findings
- Scheduled to receive the first time anthracycline-based chemotherapy
Key exclusion criteria (10 listed)
- Baseline LVEF < 50%
- Prior Statin use or Statin use is indicated based on guidelines
- history of congestive heart failure (CHF) or cardiomyopathy
- Pregnancy or breastfeeding
- Unable to provide informed consent
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 |
|---|---|---|
| Rosuvastatin 20 mg/dayConsumption of rosuvastatin 20mg tablets every day | Drug | Intervention |
| Placebo tablets similar to rosuvastatin 20mg tabletsconsumption of placebo tablets similar to rosuvastatin 20mg | Drug | Placebo |
Primary outcome
CTRCD (cancer treatment-related cardiac dysfunction)
Time frame: 12 months after randomization
CTRCD is defined as a reduction of ≥10 percentage points in LVEF by echocardiography to <53% or a >15% relative decline in global longitudinal strain (GLS) compared with baseline strain.
5 secondary outcomes
changes in LVEF
Time frame: 3, 6, and 12 months after randomization
changes in Global Longitudinal Strain (GLS)
Time frame: 3, 6, and 12 months after randomization
changes in Troponin level
Time frame: 3, 6, and 12 months after randomization
changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level
Time frame: 3, 6, and 12 months after randomization
changes in High-sensitivity C-reactive Protein (hsCRP) level
Time frame: 3, 6, and 12 months after randomization
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 10 Dec 2025.
- Individual participant dataSharing planned: Yes. The IPD used in the main analyses of CSR will be shared upon reasonable request from the principal investigator and confirmation by trial management committee (TMC).
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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.
Toba Oncology Department, Mazandaran University of Medical Sciences
Sari, Iran
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 20 mg/day in people with Anthracycline-induced Cardiac Toxicity and Breast Cancer, run by Shiraz University of Medical Sciences at 7 sites in Iran.
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 10 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Iran. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTRCD (cancer treatment-related cardiac dysfunction) (time frame: 12 months after randomization). 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 10 Dec 2025.