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CompletedNCT04588935Updated Feb 8, 2023

Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

A Phase 2 interventional study of Bisoprolol; Perindopril; in Women With Breast Cancer, sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus. Completed at 1 site in Belarus. Open to female participants. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2019, registered Oct 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study 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 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

02

Conditions studied

  • Women With Breast Cancer

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.

Exclusion criteria

Exclusion Criteria:

  • presence of other oncological diseases
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • No intervention
    Group 1

    women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated

  • Active comparator
    Group 2

    women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril

    Drug: Bisoprolol; Perindopril;

Interventions

  • DrugBisoprolol; Perindopril;

    Drug pages: Bisoprolol · Perindopril

    based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed

    Also known as: Bisoprolol; Perindopril

06

What researchers measure

Primary outcomes

  1. development of cardiovascular diseases and complications

    hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure

    Time frame: 4 years

07

Study locations

1 site
  • Scientific and Practice Center of Cardiology
    Minsk, 220000, Belarus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Feb 2023, 43 months.

Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's 43 months is below that.

Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2020
First posted
Oct 19, 2020
StartActual
Jul 1, 2019
Primary completionActual
Feb 7, 2023
CompletionActual
Feb 7, 2023
Last update
Feb 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04588935
Lead sponsor
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
Responsible party
Dr. Chernyak Sergey (Researcher, Hypertension Laboratory Republican Scientific and Clinical Cardiology Center Republic of Belarus, Belarus, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus) — Principal investigator
First posted
Oct 19, 2020
Start date
Jul 1, 2019
Primary completion
Feb 7, 2023
Completion
Feb 7, 2023
Last update
Feb 8, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Bisoprolol · Perindopril

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State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

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