Study of the association of docetaxel and liposomial doxorubicin Myocet in metastatic breast cancer phase II clinical trial - ND
- Conditions
- Patiens with metastatic breast cancerMedDRA version: 6.1Level: PTClassification code 10055113
- Registration Number
- EUCTR2006-000120-14-IT
- Lead Sponsor
- AZIENDA USL 6 LIVORNO ZONA LIVORNESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 41
- Diagnosis of metastatic breast cancer - Age 18-70 years - PS ECOG 0- 2 - measurable Disease criteria R.E.C.I.S.T. - Expectation of life to the six months - Adapted medullary functionality leukocites 3,0 109/L and neutrophil 1,5 109/L, plt 100 109/L, Hb 9g/dl - hepatic functionality bilirubina total 1,25 x UNV, transaminase 3 x UNV, alkaline phosphatase 2,5 x UNV. - Adapted renal functionality creatinine 1,3 x UNV - Patients previously deal to you with antracicline /- paclitaxel in the concluded adiuvante therapy from at least 12 months - Patients already which CMF, FEC/AC deal in front line chemotherapy to you for the metastatic disease with outlines, paclitaxel or trastuzumab in monotherapy or association and gone in progression after at least 6 months from the obtaining of an answer with such types of chemotherapy - Any type of hormonal treatment for the adiuvante and/or metastatica disease here where indicated previously - Fraction of equal cardiac ejection at least 50 with cumulative dose of not advanced epirubicina to of 540 mg/m2 - Adapted to contraception for the patients in premenopause and test of pregnancy negative in the week previous the beginning of the chemotherapy where indicated - informed Consent here written
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
- Patients with positive HER2 tumor to therapy with trastuzumab - Patients pre-treacted with Doxorubicina to any dosage - More than a chemioterapic regimen for the treatment of the metastatic disease - Patients who have previously received x-ray on the left thoracic wall - Presence of sintomatic cerebral metastases - X-ray or chemotherapy finished from less than four weeks - scompensate metabolic Diseases or infections in action - cardiac Arrhythmies or ischemic cardiopathy not controlled - acute Infarct of the myocardium in the last year - hormonal Treatment or with Herceptin in course - Impossibility to execute an adequate one follow up - Pregnancy in action
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