Cardioprevention for adjuvant treatment in breast cancer

Phase 1

• Conditions: MedDRA version: 20.1Level: PTClassification code 10008444Term: Chemotherapy cardiotoxicity attenuationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]; Female, non metastatic histologically confirmed primary invasive breast cancer scheduled to receive neoadjuvant or adjuvant anthracyclines with or without anti Her 2 therapy, LVEF >50%

• Registration Number: EUCTR2015-000914-23-IT
• Lead Sponsor: DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 480

Inclusion Criteria

Female
Age>18
Non metastatic Histologically confirmed primary breast cancer
Scheduled to receive neoadjuvant or adjuvant chemotherapy with or without anti Her 2 therapy
LVEF 50%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Pregnant or lactating women
Treatment with ACE inhibitors or beta blockers at diagnosis
History of Grade >2 symptimatic congestive heart failure, previous myocardial infarction, significative symptoms relating to LVEF disfunction, valvular disfunction, cardiac arrythmias > G3

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 24 months;Main Objective: Evaluation of reduction of both systolic and diastolic, early and late subclinical cardiotoxicity<br>measured with traditional echocardiography and pulsed tissue doppler in pharmacologically treated <br>patients compared to the placebo group;Secondary Objective: Evaluation of the reduction of symptomatic heart failure incidence in pharmacologically treated women compared to the placebo group.<br>Evaluation of predictive value of some myocardial toxicity biomarkers.;Primary end point(s): evaluation of subclinical cardiac damage, measured with conventional echography, pulsed tissue Doppler and 2D speckle tracking in treated patients compared to the placebo arm

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Endpoint: evaluation of the reduction of incidence of symptomatic heart failure and of predictive value of some cardiotoxicity biomarker;Timepoint(s) of evaluation of this end point: 24 months