A prospective study with beta-blockers and ACE-inhibitors in patients operable breast cancer experiencing mild cardiac toxicity during treatment with anthracycline and/or trastuzumab - Cardiorete

FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO0 sitesMarch 8, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 8, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO

•Women older than 18 years; Women with histological diagnosis of invasive breast cancer completely removed by surgery (any T, any N, M0\); Women eligible for adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab; Patients with HER\-2 positive tumors assessed by immunohistochemistry and/or Fluorescent in Situ Hybridization (FISH); Adequate hematopietic, hepatic and renal function; Normal cardiac function with LVEF ³ 55% at the baseline; Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 175
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 25

•Recurrent or metastatic disease; HER2 negative tumors; Concomitant cardiologic disease which would place the patient at unusual risk; LVEF \< 55% at the baseline; Concurrent conditions that contraindicate cardiologic drugs used in this study; Patients with hypertension or other disease already treated with beta\-blockers and/or ACE \-inhibitors; Concomitant severe diseases which would place the patient at unusual risk; Patients treated with systemic investigational drugs within the past 4 weeks; Pregnancy or breast\-feeding.