FEC neo-adjuvant chemotherapy followed by weekly Taxol administration combined with Trastuzumab in II-III stage HER2 positive breast cancer patients.Fase II trial. - ND

IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO0 个研究点开始时间: 2010年11月2日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•1)Female gender;2)Age = 18 years;3)ECOG Performance Status 0-1 (Appendix X);4)Histological diagnosis of infiltrating breast cancer:Primary tumor diameter = 2 cm clinically and by mammography or ultrasound or MNR measured candidate for neo-adjuvant chemotherapy-Any N-No evidence of metastasis(MO);5)HER2 overexpression and/or amplification in the invasive component of primary tumor under the following definitions:- 3+ overexpression by immunohistochemical (> 30% infiltrating tumor cells), - 2+ o 3+(in 30% or less of neoplastic cells) overexpression to immunoistochemical and gene amplification to FISH, - gene amplification to FISH( > 2.2 ratio; 6)Known hormon receptors status; 7)Hematopoietic status:absolute neutrophils number = 1.5 x 109/L,platelets = 100 x 109/L;8)Liver function:Total serum bilirubin = 1.5 x the institutional upper limit of normal (IULN) (< 2 IULN in case of Gilbert syndrome )- AST and ALT = 2.5 IULN, - alcalyne phosphatase = 2.5 IULN;9) Renal function: -creatinine = 2.0 mg/dL; 10)Cardiovascular: -baseline LVEF = 50% measure by echocardiography or MUGA scan; 11) Premenopausal patients:negative serum pregnancy test; 12)written 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) yes
•F.1.3.1 Number of subjects for this age range

•1)Male gender; 2)Histology other than adenocarcinoma; 3)Pregnant or lactating women; 4)Any prior treatment for invasive breast cancer; 5)History of uncontrolled or symptomatic angina pectoris,clinically relevant arrhythmias,congestive heart failure AMI,uncontrolled hypertension (= 180/110),unstable diabetes mellitus, dyspnea at rest, Chronic oxygen therapy 6)Uncontrolled active infetions; 7)Dementhia or any psycological or psychiatric condition that can affect the understanding and signing the Informed Consent ; 8)Concurrent neo-adjuvant therapy (chemotherapy, radiotherapy, hormonotherapy, biological therapies) 9) Any other neoplasm in the previouse 5 years except for in situ carcinoma of the cervix, basal and squamouse cell carcinoma of the skin not melanoma that have been curatively treated; 10)Any condition that makes inappropriate the patient`s participation in the study or any serious medical disorder that could affect the safety of the patient

发起方

IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO