None listed
Conditions
Brief summary
This is a randomized phase III trial in high-risk breast cancer patients, to further explore the impact of dose-density in the adjuvant treatment for breast cancer. Node-positive patients are randomized to sequential dose-dense epirubicin 110 mg/m2 for 3 cycles followed by paclitaxel (Taxol) 250 mg/m2 for 3 cycles, all cycles given every 2 weeks (group A/control group), or concurrent epirubicin 83 mg/m2 and paclitaxel 187 mg/m2 every 3 weeks for 4 cycles (group B/ interventional group), both followed by 3 cycles of ‘intensified’ combination chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF). Granulocyte colony-stimulating factor was given prophylactically with the dose-dense treatments. By protocol design, dose-intensity of epirubicin and paclitaxel, the 2 most active drugs of the regimen, were double in the control group while total cumulative dose of all drugs and duration of chemotherapy period were identical in the 2 groups. Hormonal therapy and radiation therapy were given appropriately after the completion of chemotherapy.
Interventions
Group B will be treated with epirubicin (83mg/m2) intravenous infusions of 30-60 minutes and paclitaxel (187mg/m2) 3-hour intravenous infusion every 3 weeks for four cycles followed by 3 cycles of CMF (cyclophosphamide; 840 mg/m2, methotrexate; 57 mg/m2 and fluorouracil; 840 mg/m2) intravenous infusions of 15 minutes every 2 weeks.
Granulocyte colony stimulating factor/GCSF support will be given as follows: pegulated filgrastim on day 2 of each dose-dense cycle subcutaneously administered by nu
Group B will be treated with epirubicin (83mg/m2) intravenous infusions of 30-60 minutes and paclitaxel (187mg/m2) 3-hour intravenous infusion every 3 weeks for four cycles followed by 3 cycles of CMF (cyclophosphamide; 840 mg/m2, methotrexate; 57 mg/m2 and fluorouracil; 840 mg/m2) intravenous infusions of 15 minutes every 2 weeks. Granulocyte colony stimulating factor/GCSF support will be given as follows: pegulated filgrastim on day 2 of each dose-dense cycle subcutaneously administered by nurse or filgrastim on day 3-10 subcutaneously administered by nurse. Radiation therapy (RT) is mandatory for all patients with breast-conserving surgery or for those with four or more positive lymph nodes and/or tumor size >= 5cm. Hormonal therapy (tamoxifen 20 mg/day orally) will be delivered after the completion of chemotherapy for 5 years in all hormonal receptor-positive patients. All premenopausal patients undergo ovarian suppression for 2 years.
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histology-confirmed epithelial cancer of the mammary gland. Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 Mo) 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 (GGT), 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 sane margin of 2 cm or more and the results of the axillary node dissection available. Time from surgery 2 to 4 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.
Exclusion criteria
Evidence of significant cardiac disease Patients will be ineligible if they have: 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) No previous antitumor chemotherapy or radiation
Outcome results
None listed