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.

Sex

Female

Minimum age

18 Years

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

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