Epirubicin followed by Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) versus Epirubicin and Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (ET-CMF) as adjuvant chemotherapy in node positive patients with operable breast cancer. A phase III study conducted by the Hellenic Cooperative Oncology Group.

Completed

• Conditions: High risk breast cancer patients; Cancer - Breast

• Registration Number: ACTRN12609001036202
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence[3 years from treatment initiation. <br>This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT) of thorax and abdomen and bone scan (every 6 months for the 1st year and annually since then).];Overall survival[3 year from treatment initiation]

Secondary Outcome Measures

Name	Time	Method
To compare the acute and long-term toxicity caused by the two regimens.<br>Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.[1 month since the last administration of the drug for acute toxicity and 3-5 years for long term toxicity]