VINORELBINE, CARBOPLATIN AND TRASTUZUMAB IN ADVANCED HER-2 POSITIVE BREAST CANCER. A PHASE 2 STUDY - VinCaT
- Conditions
- BREAST CANCERMedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic
- Registration Number
- EUCTR2006-003994-28-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
? Histologically confirmed HER2-positive (immunohistochemistry [IHC 3+] or fluorescence or chromogenic in situ hybridization [FISH+, CISH+]) breast cancer
? Stage IV
? Age ? 18 and < 75 years
? ECOG Performance Status 0-2
? Life expectancy >3 months
? None or at most one treatment for metastatic disease
? Neutrophils ? 2 x 109/L and Platelets ?100 x 109/L
? Total bilirubin, ASAT (GOT) and/or ALAT (GPT) ?1.25 time the upper-normal limits (UNL) of the Institutional normal values
? Adequate renal function (serum creatinine < 1.5 UNL)
? Normal Left Ventricular Ejection Fraction (LVEF) >50% (evaluated by ultrasonography).
? Measurable or evaluable disease
? Signed informed consent.
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) no
F.1.3.1 Number of subjects for this age range
? More than one prior chemotherapy for metastatic disease
? Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
? Trastuzumab treatment for metastatic disease (an adjuvant therapy with trastuzumab is allowed)
? History of prior malignancy in the last 5 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ).
? Other serious illness or medical condition
? Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia
? History of significant neurological or psychiatric disorders including dementia or seizures
? Active infection
? Geographic inaccessibility for treatment and follow up
? Pregnant or lactating women
? Male
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method