Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer - not available

CECOG0 个研究点目标入组 50 人开始时间: 2004年11月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•[1]Female patients, age between 18-75 years.
•[2]Patients with histological diagnosis of invasive breast cancer
•[3]Patients with early stage I, II and III breast cancer amendable for complete surgical resection.
•[4]Patients with any nodal status
•[5]Patients with ER and PR-negative tumors (in case of N0 disease). In case of axillary involvement: any hormonal receptor status.
•[6]Performance Status 0 or 1 on the ECOG Scale (See Attachment 1).
•[7]Patients indicated for adjuvant chemotherapy
•[10]Adequate organ function including the following:
•Adequate bone marrow reserve: absolute neutrophil count (ANC) ³ 1.5 x 109/L, hemoglobin ³ 10.0 g/dL and platelets ³ 100 x 109/L.
•Adequate renal function with serum creatinine <1.25 mg/dL.
•Adequate hepatic function: ALT and AST < 1.5 ULN (Upper Limit of Normal Range), Normal Bilirubin, Alkaline phosphatase £ 2.5 ULN
•Calcium £1.2 times the ULN.
•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

•[14]Active infection (at the discretion of the investigator).
•[15]Pregnancy
•[16]Breast-feeding.
•[17]Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
•[18]Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
•[19]Use of any other investigational agent within 4 weeks before enrollment into the study.
•[20]Concurrent administration of radiation therapy, chemotherapy, hormonal therapy, or immunotherapy (including humanized anti-HER2 antibody).

发起方

CECOG