Epirubicin followed by Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) vs Epirubicin and Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (ET-CMF) as adjuvant chemotherapy in node positive patients with operable breast cancer.A phase III study conducted by the Hellenic Cooperative Oncology Group.

Hellenic Cooperative Oncology Group0 个研究点目标入组 1,100 人开始时间: 2009年12月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Histology-confirmed epithelial cancer of the mammary gland.
•Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 Mo)
•White Blood Cells > 4 x 109/l, platelets > 100 x 109/l.
•Serum creatinine, Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltransferase (GGT), serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
•Performance status (World Health Organisation) 0 or 1.
•Age >= 18 years
•Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed sane margin of 2 cm or more and the results of the axillary node dissection available.
•Time from surgery 2 to 4 weeks
•Informed consent of the patient according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments and to individual institutional policy.

•Evidence of significant cardiac disease
•Patients will be ineligible if they have: History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (Blood Pressure> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multiple gate acquisition (MUGA) scan or echocardiogram (ECHO)
•No previous antitumor chemotherapy or radiation

发起方

Hellenic Cooperative Oncology Group