Open phase II randomized study to assess safety, tolerability and efficacy of trastuzumab combined with vinorelbine in patients with HER2 positive metastatic breast cancer and cardiac diseases - ND

Conditions: HER2 positive breast cancer
MedDRA version: 9.1Level: SOCClassification code 10038604

Registration Number: EUCTR2010-018324-13-IT

Lead Sponsor: CONSORZIO PER LA RICERCA ONCOLOGICA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Histologic diagnosis of breast cancer Metastatic breast cancer upon progression from prior treatment HER-2 positive at either FISH or CUSH or 3+ on immunohistocemistry al local laboratory Ability to give informed consent Age >= 18 years ECOG PS 0-2 Measurable or evaluable disease Total cumulative dose of previous anthrcyclines <= 300 mg/mq Left ventricular ejection fraction >= 45% at echocardiography or MUGA Diagnosis of al leat one of the following cardiovasculare diseases:  heart failure  high risk uncontrolled arithmia  Angina pectoris under treatment  Clinically significant valvular diseases  Previous (>= 6 months prior to registration) transmural cardiac infarction  Uncontrolled arterial hypertension despite adequate treatment (systolic pressure > 160 and/or diastolic pressure > 100) Adequate hematological and biochemical values Life expenctancy >= 90 giorni
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Less than 21 days from the last antineoplastic therapy. Previous irradiation is allowed provided is not on the only site of disease Known hypersensitivity or intolerance to trastuzumab and hystory of previous trastuzumab-related adverse events leading to definite treatment discontinuation Left ventricular ejection fraction < 45% at echocardiography or MUGA Previous vinorelbine for metastatic disease Known active HIV infection, hepatitis B or C Pregnancy or lactation Severy other non malignant systemic diseases Ohter malignancies in the previous 5 years except in situ cervix carcinoma, basal cell carcinoma or HER2 positive breast cancers, syncronous or metacronous

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the frequency of cardiac adverse event (major and minor) in patients with HER2 positive metastatic breast cancer and cardiac diseases treated with trastuzumab and in patients not given trastuzuman;Secondary Objective: 1. To assess frequency of all adverse events in both group of patients 2. To assess the rate of objective clinical remissions, progression-free survival, time to progression and overall survival in both patient groups 3. To assess PK of trastuzumab as given in this study;Primary end point(s): Frequency of major and minor cardiac adverse events during treatment or within two months after discontinuation

Secondary Outcome Measures