Figure 2
Treatment scheme of the European Organization for Research and Treatment of Cancer (EORTC) 10994 p53 trial. * Each collaborating group will choose one of these two options before entering the patients into the trial. Arm A: FEC 100 (EORTC, Anglo-Celtic and SAKK [Swiss Group for Clinical Research] groups), 500 mg/m2 fluorouracil, 100 mg/m2 epirubicin, 500 mg/m2 cyclophosphamide every 3 weeks for six cycles [12]; or tailored FEC (Swedish group), all patients will start at the first course on day 1 with 600 mg/m2 fluorouracil intravenously (IV) on day 1, 75 mg/m2 epirubicin IV on day 1, 900 mg/m2 cyclophosphamide IV on day 1 every 3 weeks for six cycles; 5 μg/kg granulocyte-colony stimulating factor (G-CSF) on days 5–12 and 500 mg ciprofloxacin orally twice daily on days 5–15 [13]. Arm B: 100 mg/m2 docetaxel every 3 weeks for three cycles, followed by 90 mg/m2 epirubicin and 75 mg/m2 docetaxel every 3 weeks without G-CSF for three cycles. ** In case of progressive disease (PD) after a minimum of two cycles, the patient will be off study. *** Locoregional treatment and hormonotherapy: in the absence of locoregional progression, surgical and radiation therapy treatment will be planned according to the guidelines detailed in the full protocol. Tamoxifen (20 mg/day for 5 years) will be prescribed at the end of neoadjuvant chemotherapy in patients with estrogen receptor-positive and/or progesterone receptor-positive tumours. RAND, randomization.