AERO-B03: A randomized phase II trial of dose-dense docetaxel in node-positive breast cancer

647 Background: Administration of taxanes every 2 weeks (q2w), or “dose dense therapy”, is one of the most promising chemotherapy regimens in node positive (N+) breast cancer. AERO-B03 is a randomized phase II trial designed to assess the feasibility of docetaxel dose dense regimens in this setting. Methods: From December 2003 to September 2004, 100 patients (pts) with N+ breast cancer were randomized to receive 6 TEC (docetaxel 75 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 q3w) (control), 4 EC (epirubicin 100 mg/m2 and cyclophosphamide 600 mg/m2 q2w) followed by 4 T (docetaxel 100 mg/m2 q2w) (dose dense A) or 4 T followed by 4 EC (dose dense B). Pegfilgrastim was administered on day 2 of each cycle. Primary endpoint was grade 4 (G4) toxicity. Any of the 3 arms would be rejected from further study if G4 ≥ 50%. Data were reviewed by an independent safety monitoring committee. Results: Preliminary results are based on the first 61 pts (21 pts in control, 21 pts in dose dense A, and 19 in dose...