Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer
In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF
chemotherapy of methotrexate with epirubicin improves survival for patients with primary and
operable breast cancer. In a retrospective evaluation we have also shown that approximately
20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that
only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG
wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel
and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in
patients with TOP2A normal and operable breast cancer.
1. Younger than 35, but at least 18 years of age
2. Hormone receptor-negative tumor (ER- and PgR-negative) and 35 to 75 years of age.
3. Hormone receptor-positive tumor, 35 to 59 years of age and presenting at least one of
the following characteristics: spread to lymph nodes, tumor > 2 cm, degree of
malignancy II-III or HER2-positive.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
IDFS; invasive disease-free survival
Bent Ejlertsen, M.D.
Denmark: Danish Medicines Agency