Epirubicin/Paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) as adjuvant chemotherapy in high-risk patients with operable breast cancer
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12615000161527
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1000
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the prognostic role of selected biomarkers on the tiime from study entry to recurrence (disease free survival-DFS) [3 years. All patients will be followed at the clinic every 6 months and annually thereafter with clinical examination, CBC, complete biochemistry, serological markers, chest X- ray, bone scan (only for the first 3 years of follow-up and thereafter if clinical indicated) and mammography (annually). Since this is an adjuvant study, follow-up will be continued for the following years (until progression or death for individual patients).];To evaluate the prognostic role of selected biomarkers (gene mutation identified by next generation sequencing and DFS, OS according to immunohistochemically defined subtypes) on overall survival [The biomarkers are collected prospectively prior to commencement of treatment.]
- Secondary Outcome Measures
Name Time Method The secondary objective is the evaluation of the acute toxicity. [1 month since the last administration of chemotherapy for acute toxicity.1 month since the last infusion of Trastuzumab for those patients who receive the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc. ];The secondary objective is the evaluation of long-term toxicity [Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc. throughout the follow-up period of the patients (for up to 10 years post completion of treatment).]