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

• Conditions: patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002207-15-IT
• Lead Sponsor: FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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