Phase II Study of neoadjuvant therapy with trastuzumab plus docetaxel followed by trastuzumab plus pegylated liposomal doxorubicin and cyclophosphamide in human ErbB-2-positive operable or locally advanced breast cancer - CETRA
- Conditions
- Operable breast cancer patients or locally advanced breast cancer patients (stage II-III), with HER2 overexpression or gene amplificationMedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female
- Registration Number
- EUCTR2006-003993-85-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
- ot Recruiting
- 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 II-IIIB (T0-1-2-3-4-N+-M0, T2-3-4-N0-M0) ? Age ? 18 and < 65 years ? ECOG Performance Status 0-1 ? Life expectancy >3 months ? Neutrophils ? 2 x 109/L and Platelets ?100 x 109/L ? Total bilirubin ?1.25 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (GOT) and/or ALAT (GPT) ? 1.25 UNL. ? Creatinine ? 1.25 the UNL ? Normal Left Ventricular Ejection Fraction (LVEF) >50% (evaluated by MUGA scan or ultrasonography ? only one method must be employed for an individual patient). ? 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
? Stage IV ? Prior chemotherapy ? History of prior malignancy in the last 10 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 ? Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening ? Geographic inaccessibility for treatment and follow up ? Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the activity (rate of pathologic complete response [pCR]) of a neoadjuvant therapy consisting of 4 cycles of trastuzumab plus docetaxel followed by 4 cycles of trastuzumab plus pegylated liposomal doxorubicin plus cyclophosphamide in HER2-positive operable or locally advanced breast cancer;Secondary Objective: ? To describe the activity and the tolerability of the treatment scheme ? To assess the capability of non-invasive diagnostic procedures (PET, color-Doppler ultrasound) to predict patient response to neo-adjuvant treatment;Primary end point(s): ? To describe the activity (rate of pathologic complete response [pCR]) of a neoadjuvant therapy consisting of 4 cycles of trastuzumab plus docetaxel followed by 4 cycles of trastuzumab plus pegylated liposomal doxorubicin plus cyclophosphamide in HER2-positive operable or locally advanced breast cancer
- Secondary Outcome Measures
Name Time Method