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)

Phase 3

Completed

• Conditions: high-risk operable breast cancer; Cancer - Breast

• Registration Number: ACTRN12611000506998
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS). <br>DFS was measured from randomization until local recurrence, distant relapse or death from the disease without relapse.[5 years from study initiation]

Secondary Outcome Measures

Name	Time	Method
Translational Research of Human Epidermal growth factor Receptor 2 (HER2) status and other biomarkers like: basal marker, angiogenesis, BRCA1 etc.<br>We collect paraffin embedded tumor tissue at baseline.<br>The samples are assessed by immunohistochemistry, Fluorescent in situ hybridization (FISH), Chromogenic In Situ Hybridization (CISH), polymerase chain reaction (PCR).[Results are correlated with outcome at 5 years and 8 years];Overall Survival (OS). <br>OS was measured from the date of randomization until death from any cause.[5 years from study initiation];Acute toxicity[Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc. <br>1 month since the last administration of chemotherapy for acute toxicity];Quality of Life. We use the EUroQol (EQ-5D) evaluation questionnaire[Baseline-End of Chemotherapy]