A randomized phase III trial with dose-dense sequential chemotherapy with epirubicin/paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (CMF) vs epirubicin/CMF/docetaxel or paclitaxel as adjuvant chemotherapy in high-risk patients with operable breast cancer.
- Conditions
- High risk breast cancer patientsCancer - Breast
- Registration Number
- ACTRN12610000151033
- 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the time from initial operation to recurrence (disease free survival-DFS)[3 year. All patients will be followed at the clinic every 6 months for 5 years and then annually thereafter for up to 10 years with clinical examination, complete blood count (CBC), complete biochemistry, serological markers, chest X- ray, bone scan (only for the first 3 years of follow-up) and mammography (annually).];To compare the overall survival. This outcome is assessed using clinical data records[3 year following commencement of chemotherapy]
- Secondary Outcome Measures
Name Time Method The secondary objective is the comparison of the acute and long-term toxicity caused by the 3 regimens.[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.];Quality of Life. <br>We use the EUroQol (EQ-5D) valuation questionnaire[Baseline-End of Chemotherapy-6 months after the completion of chemotherapy (and/or Trastuzumab)]