Women With Breast CancerPhase 2NCT04588935
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
A Phase 2 study testing Bisoprolol; Perindopril; in people with Women With Breast Cancer, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
Trial summary
To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Women With Breast Cancer
- What is being tested?
- Bisoprolol; Perindopril;
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2019to 7 Feb 2023
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.
Who cannot join
- presence of other oncological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications
Read the detailed description
Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications
- Conditions
- Women With Breast Cancer
- Being tested
- Bisoprolol; Perindopril;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisoprolol; Perindopril;Drug
Also called Bisoprolol; Perindopril
based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated |
| Group 2 | Active comparator | women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril Receives: Drug: Bisoprolol; Perindopril; |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of cardiovascular diseases and complications
hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jul 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chernyak Sergey, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588935
- Sponsor's protocol ID
- 20192755
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
- ClinicalTrials.gov ID
- NCT04588935
- Acronym / sponsor ID
- 20192755
- Conditions
- Women With Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, BelarusUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 19 Oct 2020 (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.
To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications
Detailed description
Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated |
| Group 2 | Active comparator | Drug: Bisoprolol; Perindopril;women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.
Key exclusion criteria (1 listed)
- presence of other oncological diseases
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 |
|---|---|---|
| Bisoprolol; Perindopril;Also: Bisoprolol; Perindoprilbased on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed | Drug | Group 2 |
Primary outcome
development of cardiovascular diseases and complications
Time frame: 4 years
hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure
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 8 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bisoprolol; Perindopril; in people with Women With Breast Cancer, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
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 1 inclusion and 1 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 8 Feb 2023. 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 Belarus. 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 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?
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?
development of cardiovascular diseases and complications (time frame: 4 years). 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 8 Feb 2023.