A comparison of disease-free and overall survival following dose-dense sequential chemotherapy with epirubicin/paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (CMF) vs epirubicin/CMF/weekly docetaxel or weekly paclitaxel as adjuvant chemotherapy in high-risk patients with operable breast cancer. A 3-arm randomized phase III study conducted by the Hellenic Cooperative Oncology Group

Hellenic Cooperative Oncology Group0 个研究点目标入组 1,000 人开始时间: 2010年2月15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 operable breast cancer and involved axillary lymph nodes (T 1-3 N1-2 Mo) or patients without involved axillary nodes (T1-3 N0 Mo) (i.e. those with T>= 2cm or T>1cm with at least one of the following: grade 3, age < 34 years, negative hormonal status, infiltration of blood vessels or lymphatic vessels or nerves, HER-2 (receptor tyrosine kinase) overexpression, high S fraction). 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 (gamma-GT), 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 safe margin and the results of the axillary node dissection available.No evidence of significant cardiac disease. No previous antitumor chemotherapy or radiation.Time from surgery 2 to 8 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.

•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).Documented residual or metastatic disease.Prior chemotherapy, hormonal or radiation treatmentPregnant or in puerperium period women, or patients unwilling to follow adequate contraceptive methods during treatment period. History of prior cancer except for curatively treated basal-cell carcinoma of the skin or in situ carcinoma of the cervix uteri. Patients who can not fully understand and complete the inform consent form, or patients who can not follow treatment or follow up schedule.

发起方

Hellenic Cooperative Oncology Group