ACTRN12611000506998
Completed
Phase 3
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 Group0 sites600 target enrollmentMay 16, 2011
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hellenic Cooperative Oncology Group
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •\- 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).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Epirubicin/Paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) as adjuvant chemotherapy in high-risk patients with operable breast cancerBreast CancerCancer - BreastACTRN12615000161527Hellenic Cooperative Oncology Group1,000
Completed
Not Applicable
Investigation of the prognostic role of protein expression, mRNA levels, gene amplification and mutation of key cellular elements in patients with breast cancer treated with dose-dense sequential adjuvant chemotherapyBreast CancerCancer - BreastACTRN12616001043426Hellenic Cooperative Oncology Group1,060
Completed
Not Applicable
Selection of Breast Cancer Patients with Low-risk Tumors using MR ImagingNL-OMON36966niversitair Medisch Centrum Utrecht60
Completed
Not Applicable
Prevention of breast cancer in high risk women by monitoring microrna expression in nipple aspirate fluid.breast cancerbreast carcinoma100836241000629110006232NL-OMON44762niversitair Medisch Centrum Utrecht720
Completed
Not Applicable
High Dose Therapy in Poor-Risk Primary Breast CancerBreast cancerCancerBreastISRCTN52623943Amgen Limited (UK)