[52] BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients.

Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Pawlicki M, Chan A, Smylie M, Liu M, Falkson C, Pinter T, Fornander T, Shiftan T, Valero V, Mackey J, Tabah-Fisch I, Buyse M, Lindsay M, Riva A, Bee V, Pegram M, Press M, Crown J.. UCLA, Los Angeles, CA; GBG, Munchen, Germany; US Oncology, Houston, TX; Maria Sklodowska-Curie (MSC) Centre, Warsaw, Poland; GEICAM, Madrid, Spain; MSC Institute, Krakow, Poland; Mount Hospital, Perth, Australia; Cross Cancer Institute, Edmonton, AB, Canada; Sun Yat-Sen Cancer Center, Taipei, Taiwan; University of Alabama, Birmingham, AL; Petz Aladar County, Gyor, Hungary; OnkologyKliniken, Stockholm, Sweden; Sharp Healthcare, San Diego, CA; MD Anderson Cancer Center, Houston, TX; Sanofi-Aventis, Paris, France; IDDI, Brussels, Belgium; CIRG, Paris, France; USC, Los Angeles, CA

Background: Evaluation of the benefit of biologically-based regimens of trastuzumab in the early breast cancer population, and optimization of trastuzumab integration to maximize efficacy and minimize cardiac toxicity.
Material and Methods: We randomized HER2 positive (FISH) breast cancer patients (pts) with axillary lymph node positive or high risk negative, to either standard AC (60/600 mg/m² q3wk x4) followed by T (100 mg/m² q3wk x4) or two trastuzumab-containing regimens; AC followed by T with trastuzumab x 1 year or TCarbo (75 mg/m² / AUC6 q3wk x6) with trastuzumab x 1 year. Pts were prospectively stratified by number of positive nodes (0, 1-3 vs 4+) and hormone receptor status. Pts with ER and/or PR positive (HR+) tumors received hormone-directed therapy for 5 yrs after chemotherapy. The primary endpoint was disease-free survival (DFS) with 80% power (0.05 significance level) to detect an absolute difference of 7%. Secondary endpoints included overall survival (OS) and safety, including extensive cardiac toxicity (symptomatic events and asymptomatic LVEF decline). We will report the results of the protocol-mandated second interim analysis conducted after 450 events, expected by September 06.
Results: A total of 3222 pts (1072 in AC-T, 1076 in AC-TH and 1074 in TCH) were recruited between April 01 and March 04. Baseline characteristics of the study population will be included. Cox analysis of DFS and OS (unadjusted and adjusted for nodal status) and cardiac toxicity data will be presented for the 3 treatment arms.Discussion: The results of this trial will help define the role of trastuzumab in the breast cancer HER2 positive adjuvant setting, as well as evaluate the benefit of adjuvant trastuzumab within the context of global cardiac safety. This latter point is of particular importance given that many women may be cured of their disease in the adjuvant setting.

Thursday, December 14, 2006 3:30 PM

General Session 2 (2:00 PM-3:30 PM)