TEX (NCT01433614) is a multicenter, randomized phase III trial that evaluated the activity of epirubicin and paclitaxel, with or without capecitabine, as first-line treatment for locally advanced inoperable or metastatic BC using tailored doses depending on treatment side effects. Study PI is Thomas Hatschek. In total, 304 patients were included. Enrollment of patients with HER2+ breast cancer was discontinued when trastuzumab was shown to improve survival, while a third arm with FEC was closed soon after the trial started (287 patients ET vs TEX).

Metastatic biopsies have been collected from 149 patients.

ARIADNE trial overview

Relevant publications:

  1. “Immune gene expression and response to chemotherapy in advanced breast cancer.”.
    T. Foukakis et al.
    Br J Cancer, vol. 118, no. 4, pp. 480–488, Feb. 2018

  2. “Prognostic and predictive implications of sterile alpha motif and HD domain-containing protein 1 (SAMHD1) expression in breast cancer.”.
    M. Kouvaraki et al.
    Int J Cancer, vol. 156, no. 8, pp. 1621–1633, Apr. 2025