NCT04588935

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

October 9, 2020

Last Update Submit

February 7, 2023

Conditions

Women With Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • development of cardiovascular diseases and complications

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

    4 years

Study Arms (2)

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

Drug: Bisoprolol; Perindopril;

Interventions

Bisoprolol; Perindopril;DRUG

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
Group 2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • presence of other oncological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific and Practice Center of Cardiology

Minsk, 220000, Belarus

Location

MeSH Terms

Interventions

BisoprololPerindopril

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Hypertension Laboratory Republican Scientific and Clinical Cardiology Center Republic of Belarus, Belarus

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

July 1, 2019

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)