High-risk patients with operable breast cancer treated with adjuvant Epirubicin/Paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF). An observational study of the prognostic role of selected biomarkers on disease free survival and overall survival (HE10/08).

Hellenic Cooperative Oncology Group0 个研究点目标入组 1,000 人开始时间: 2015年2月19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 >= 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). WBC > 4 x 109 / l, platelets > 100 x 109 / l. Serum creatinine, SGOT, SGPT, gamma-GT, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.Performance status (WHO) 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 (BP> 200/110 mm Hg). A normal baseline LVEF should be demonstrated by MUGA scan or ECHO. -Documented residual or metastatic disease. -Prior chemotherapy, hormonal or radiation treatment -Pregnant 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