Epirubicin-Paclitaxel-Cyclophosphamide Methotrexate Fluorouracil (E-T-CMF) versus Epirubicin-Cyclophosphamide Methotrexate Fluorouracil (E-CMF) as adjuvant chemotherapy in high risk patients with operable breast cancer. A phase III study conducted by the Hellenic Cooperative Oncology Group (HE10/97)
High-risk patients with operable breast cancer treated with Epirubicin followed by Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) or Epirubicin followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-CMF) as adjuvant chemotherapy to investigate the effect of the treatment on disease-free survival and overall survival.
Hellenic Cooperative Oncology Group
600 participants
Jun 11, 1997
Interventional
Conditions
Summary
The aim of this phase III, randomized study was to explore the effect of dose-dense sequential chemotherapy with or without paclitaxel primarily on disease-free survival (DFS) and secondarily on overall survival (OS) in patients with high-risk operable breast cancer. Acute toxicity and quality of life were also investigated. Translational research studies were also performed.
Eligibility
Inclusion Criteria1
- Histologically-confirmed epithelial cancer of the mammary gland. -Premenopausal patients with T1 to T2 classification with histologically-confirmed invasion of axillary lymph nodes (N1 classification) or T3 and N0 or N1 classification. -Postmenopausal patients with T1 to T2 classification and > 4 positive axillary nodes or T3 and N0 or N1 classification. - White Blood Cells (WBC) >4x10^9/litre, platelets >100 x10^9 /litre. -Serum creatinine, Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltranspeptidase (gamma-GT), serum bilirubin < = 1.3 milligram/milliliter (mg/ml) or inside the normal range of the participating hospital. -Performance status (World Health Organization) 0 or 1. -Age >= 18 years. -Previous surgical treatment: Either radical surgery (i.e. total, radical or modified radical mastectomy), 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 Criteria2
- Previous antitumor chemotherapy or radiation
- 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 millimetres of mercury (mmHg). In high risk patients a normal baseline left ventricular ejection fraction (LVEF) should be demonstrated by Multi Gated Acquisition Scan (MUGA) scan or echocardiogram (ECHO).
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Interventions
epirubicin [110 milligram/square meter (mg/m2) intravenously infused over 30 minutes] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (250 mg/m2, intravenously infused over 3 hours) every 2 weeks and 3 cycles of CMF (cyclophosphamide; 840 mg/m2, methotrexate; 57 mg/m2 and fluorouracil; 840 mg/m2 intravenously infused over 30 minutes) every 2 weeks
Locations(1)
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ACTRN12611000506998