Upregulation of HER-2/neu is independent of the menopausal status of primary breast cancer patients: Plasma results from a prospectively randomized trial comparing dose-intense chemotherapy with G-CSF support to 3-weekly chemotherapy for adjuvant therapy of nodal-positive (1–3 LN) breast cancer (German Adjuvant Study Group ASG)

638 Background: The ASG is completing recruitment into an adjuvant trial in which breast cancer patients (pts) either receive conventional ECP (Arm A; epirubicin (E): 90 mg/m2 + cyclophosphamide (C) 600 mg/m2 x4 q3w, followed by paclitaxel (P) 175 mg/m2 x4 q3w) or dose-dense EP + G-CSF on days 5–13 (Arm B; E: 120 mg/m2 x4 q2w, followed by P: 175 mg/m2 x4 q2w). Plasma for circulating HER-2/neu, EGFR and CA 27.29 levels is prospectively collected at baseline, at the end of chemotherapy and at relapse. Methods: Circulating HER-2/neu is measured using a standardized ELISA assay (Bayer Diagnostics/Oncogene Science, Cambridge, USA). The nonparametric analysis of variance for repeated measurements is used to detect significant influences of treatment arm, menopausal status and time effects, and to determine interactions. Results: Longitudinal plasma results (baseline and end of chemotherapy) are available from 415 pts of which 53% are postmenopausal. HER-2/neu concentrations increased from 9.4/9.3 ng/mL (Arm A/B...