A feasibility study of dose-dense FEC wiith G-CSF support followed by dose-dense Ixabepilone wiith G-CSF support as neoadjuvant chemotherapy in ER- negative breast cancer - GIM9 (NEO-ADIXERN)

CONSORZIO ONCOTECH0 个研究点开始时间: 2008年12月23日最近更新: 2012年3月19日

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•1.Histological documented diagnosis of breast cancer by incisional biopsy 2.Clinical T.2 (T > 2cm) 3.ER negative breast cancer, independently from PgR and HER2 status 4.Females age .18 and .70 years 5.ECOG performance status 0-1 6.No prior treatment for breast cancer excluding therapy for DCIS 7.Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy 8.Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L 9.Total bilirubin < 1.5 time the upper limit of normal (ULN) of the Institutional normal values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN 10.Serum creatinine < 1.5 times the upper limit of normal 11.Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients) 12.Negative pregnancy test prior to inclusion in the study (if potentially childbearing) 13.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) yes
•F.1.3.1 Number of subjects for this age range

•1.Prior or current history of ipsilateral or controlateral breast invasive cancer. A past or current history of ipsilateral ductal carcinoma in situ or ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as well as a controlateral ductal carcinoma in situ removed by mastectomy 2.Metastatic breast cancer (M1) 3.Histology other than adenocarcinoma of the breast 4.Male patients 5.Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) 6.Patients unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational drug 7.History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ 8.Symptomatic peripheral neuropathy grade 2 according to the NCI CTC

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