Back to resultsPrevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
Primary Purpose
Women With Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
Bisoprolol; Perindopril;
Sponsored by
About this trial
This is an interventional prevention trial for Women With Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.
Exclusion Criteria:
- presence of other oncological diseases
Sites / Locations
- Scientific and Practice Center of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated
women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril
Outcomes
Primary Outcome Measures
development of cardiovascular diseases and complications
hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure
Secondary Outcome Measures
Full Information
NCT ID
NCT04588935
First Posted
October 9, 2020
Last Updated
February 7, 2023
Sponsor
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
1. Study Identification
Unique Protocol Identification Number
NCT04588935
Brief Title
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 7, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril
Intervention Type
Drug
Intervention Name(s)
Bisoprolol; Perindopril;
Other Intervention Name(s)
Bisoprolol; Perindopril
Intervention Description
based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed
Primary Outcome Measure Information:
Title
development of cardiovascular diseases and complications
Description
hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure
Time Frame
4 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.
Exclusion Criteria:
presence of other oncological diseases
Facility Information:
Facility Name
Scientific and Practice Center of Cardiology
City
Minsk
ZIP/Postal Code
220000
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
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