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 sites1,000 target enrollmentFebruary 19, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 19, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Observational

Sex

Female

Sponsor

Hellenic Cooperative Oncology Group

•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.