Background: A large adjuvant trial programme is exploring the role of capecitabine (C) in early breast cancer (EBC). CIBOMA 2004-01/GEICAM 2003-11 is a multicenter, international randomised phase III trial that focuses on adjuvant C maintenance therapy after conventional induction chemotherapy in triple-negative EBC. Here we report interim safety data from the trial.

Materials and methods: Patients (pts) with operable, node-positive (or node-negative with tumour diameter ≥1 cm), hormone receptor-negative, HER2-negative EBC (central laboratory confirmation) who have received standard anthracycline-and/or taxane-containing chemotherapy in the (neo)adjuvant setting are eligible. Pts are randomised to receive 8 cycles of C (1000 mg/m2 bid, d1-14 q21d) (Arm A) or observation (Arm B). The primary endpoint is disease-free survival (DFS). Assuming 30% risk reduction in DFS rate at 5 years (from 64.7% to 73.7%, HR of 0.701) with a power of 80% and a two-tailed log-rank test at 0.05, 834 evaluable patients will be needed. With an expected drop-out rate of 5%, 876 pts will be included. We anticipate completing recruitment by the end of 2010. Efficacy analysis will be triggered after 255 events.

Results: To date, 724 pts have been recruited; here we report safety data from the first 278 pts (136 in Arm A and 142 in Arm B). Baseline characteristics are well balanced between the treatment arms.

Baseline Characteristics

In total, 920 cycles of C were administered (median 8.0, range 0-8). All 8 cycles were completed by 74.3% of pts. Median relative dose-intensity of C was 91.1%. The most common grade 3/4 clinical AEs related to C were: hand-foot syndrome (Grade 3 19.1%), diarrhoea (3.0%), vomiting (1.5%), fatigue (1.5%), nail changes (1.5%) and bilirubin elevation (1.5%).

Conclusions: The safety profile of adjuvant C as maintenance therapy is consistent with its known toxicity profile. Safety data from the first 400 randomised pts will be reviewed by an Independent Data Monitoring Committee and used to update this analysis at the meeting.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-10-15.