Cardioprevention for adjuvant treatment in breast cancer

Cardiac toxicity prevention in non-metastatic breast cancer patients treated with anthracycline-based chemotherapy: a randomized, placebo controlled, phase 3 trial - SAFE trial. - SAFE2014

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000914-23-IT

Enrollment

480

Registered

2020-11-04

Start date

2016-08-05

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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% MedDRA version: 20.1 Level: PT Classification code 10008444 Term: Chemotherapy cardiotoxicity attenuation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: SEQUACOR - 90 COMPRESSE IN BLISTER PVC/AL DA 5 MG Product Name: SEQUACOR Product Code: [C07AB07] Pharmaceutical Form: Tablet INN or Proposed INN: BISOPROLOLO FUMARATO CAS Number: 66722-44-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Evaluation of the reduction of symptomatic heart failure incidence in pharmacologically treated women compared to the placebo group. 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;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 measured with traditional echocardiography and pulsed tissue doppler in pharmacologically treated patients compared to the placebo group	—

Measure

Time frame

Secondary Objective: Evaluation of the reduction of symptomatic heart failure incidence in pharmacologically treated women compared to the placebo group. 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;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 measured with traditional echocardiography and pulsed tissue doppler in pharmacologically treated patients compared to the placebo group

—

Secondary

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactServizio Informazione sulla Sperime

Dipartimento di Scienze Biomediche Sperimentali e Cliniche "mario serio"

lorenzo.livi@unifi.it0552751835

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026