SPONTANEOUS STUDY WITH ADJUVANT TRASTUZUMAB HERCEPTIN IN WOMEN WITH HER-2 POSITIVE PRIMARY BREAST CANCER WHO HAVE COMPLETED ADJUVANT CHEMOTHERAPY - HERMA

Conditions: PATIENTS WITH BREAST CANCER OPERATED HER-2
MedDRA version: 6.1Level: PTClassification code 10057654

Registration Number: EUCTR2005-005274-71-IT

Lead Sponsor: IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 20

Inclusion Criteria

Female gender Age 61619; 61472;18 years Eastern Cooperative Oncology Group ECOG performance status 1 Signed written informed consentE Overexpression of HER2 in the invasive component of the primary tumor, according to one of the following definitionsD - 3 overexpression by IHC - 2 overexpression by IHC AND fluorescence in situ hybridisation FISH test PathVysion or INFORM 61650; 61472;HER-2/neu demonstrating C-erbB2 gene amplification ratio of c-erbB2 gene signals to centromere 17 signals 2 - c-erbB2 gene amplification by FISH ratio of c-erbB2 gene signals to centromere 17 signals 2 Completion of adjuvant chemotherapy and radiotherapy for all patients undergoing radiotherapy Adequate bone marrow, liver and renal functions Baseline LVEF 55 measured by echocardiography or MUGA scan
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

Metastatic breast carcinoma Pregnant or lactating women Other serious cardiac illness or medical condition A including but not confined to o History of documented congestive heart failure CHF o High-risk uncontrolled arrhythmias o Angina pectoris requiring antianginal medication o Clinically significant valvular heart disease o Evidence of transmural infarction on ECG o Poorly controlled hypertensionF e.g. systolic 180mm Hg or diastolic greater than 100mm Hg Baseline LVEF 55 measured by echocardiography or MUGA scan