Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer
Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer
This study was a transnational pooled analysis of biological material from patients with
 resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and
 cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.
This was a transnational analysis of biological material from patients with resected high
 risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated
 departments of oncology. This study was a pooled analysis of two separate sequential
 feasibility studies who received the below described treatment. Patients who participated
 were 18 years old or older, women of any menopausal status who received epirubicin for 3
 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3
 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of
 each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients
 with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All
 postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5
 years. RT was required for all patients (pre- or post -menopausal), providing that they had
 either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes,
 irrespectively the type of surgery (conservative or radical).
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 M0) or high-risk N0 patients. A N0 patient is considered "high-risk"
 if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor
 (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or
 lymphatic vessels or nerves, grade 3.

 -  White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l.

 -  Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase
 (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal
 range of the participating hospital.

 -  Performance status (WHO) 0 or 1.

 -  Age >=18 years

 -  Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a
 histologically confirmed safe margin of 2 cm or more and the results of the axillary
 node dissection available.

 -  No evidence of significant cardiac disease

 Exclusion Criteria:

 -  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 (BP> 200/110 mm Hg). A
 normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by
 multigated acquisition (MUGA) scan or echocardiogram.

 -  No previous antitumor chemotherapy or radiation

 -  Time from surgery 2 to 4 weeks