Chemotherapy-induced CardiotoxicityPhase 3NCT05338723
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
A Phase 3 study testing Rosuvastatin 20mg in people with Chemotherapy-induced Cardiotoxicity and Breast Cancer, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- What is being tested?
- Rosuvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 15 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 25-75 years old.
- Gender: female
- Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%.
- Patients with normal renal and hematological functions.
- Alanine amino transferase (ALT ≤ 3 times ULN).
Who cannot join
- Pregnant or lactating females.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
- Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)<50%.
- Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy.
- Alanine amino transferase (ALT > 3 times ULN).
- Patients already taking statins or other lipid lowering therapy.
- Patients with a known hypersensitivity to any of the used drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The Department of Clinical Oncology, Tanta University Hospital
Tanta
About this study
This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.
- Conditions
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- Being tested
- Rosuvastatin 20mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20mgDrug
20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).
| Study group | Role | What they receive |
|---|---|---|
| control-group | No intervention | This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy. |
| rosuvastatin-group | Active comparator | This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). Receives: Drug: Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF
Measured: 6 months
Secondary outcomes (4)
change of serum level of High sensitivity troponin I (hs-TnI).
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI).
Measured: 6 months
change of serum level of Myeloperoxidase (MPO).
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO).
Measured: 6 months
change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6).
Measured: 6 months
change of serum level of Liver function test (ALT).
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).
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 posted21 Apr 2022
- Study start15 Sep 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced CardiotoxicityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khlood Mohamed Kettana, Tanta University
- Investigators
- khlood m. kettana, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338723
- Sponsor's protocol ID
- rosuva2020
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05338723
- Acronym / sponsor ID
- rosuva2020
- Conditions
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 21 Apr 2022 (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 investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control-group | No intervention | –This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy. |
| rosuvastatin-group | Active comparator | Drug: Rosuvastatin 20mgThis group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 25-75 years old.
- Gender: female
- Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%.
Key exclusion criteria (7 listed)
- Pregnant or lactating females.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
- Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)<50%.
- Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy.
- Alanine amino transferase (ALT > 3 times ULN).
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 20mg20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). | Drug | rosuvastatin-group |
Primary outcome
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
Time frame: 6 months
Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF
4 secondary outcomes
change of serum level of High sensitivity troponin I (hs-TnI).
Time frame: 6 months
change of serum level of Myeloperoxidase (MPO).
Time frame: 6 months
change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).
Time frame: 6 months
change of serum level of Liver function test (ALT).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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. This study is not recruiting at the moment.
khlood m. kettana principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin 20mg in people with Chemotherapy-induced Cardiotoxicity and 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 7 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography (time frame: 6 months). 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 28 Feb 2024.