Study of the association of docetaxel and liposomial doxorubicin Myocet in metastatic breast cancer phase II clinical trial - ND

AZIENDA USL 6 LIVORNO ZONA LIVORNESE0 个研究点目标入组 41 人开始时间: 2006年3月14日最近更新: 2012年3月19日

试验速览

暂无简介。

•- 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

发起方

AZIENDA USL 6 LIVORNO ZONA LIVORNESE