PREDIX HER2 (NCT02568839) is an academic, multicenter, phase 2, randomized clinical trial. Study PI is Thomas Hatschek. The trial was conducted 2014-2018 at 9 sites in Sweden and 202 patients were enrolled.

Eligible patients had a newly diagnosed HER2+ early breast cancer and were randomized to 6 three-weekly cycles of the combination of trastuzumab, pertuzumab and docetaxel, or trastuzumab-emtansine as neoadjuvant therapy. All patients received adjuvant anthracyclines. Patients who did not respond to treatment after 2 cycles switched to the other study arm. The primary endpoint of the trial was locally assessed pathologic complete response to treatment.

Blood samples and core tumor biopsies were obtained from all patients at baseline, after 2 cycles and at surgery. Response to treatment was monitored with radiological assessments and FDG-PET.

PREDIX HER2 trial overview

Relevant publications:

  1. “Neoadjuvant Trastuzumab, Pertuzumab, and Docetaxel vs Trastuzumab Emtansine in Patients With ERBB2-Positive Breast Cancer: A Phase 2 Randomized Clinical Trial.”.
    T. Hatschek et al.
    Jama Oncology, vol. 7, no. 9, pp. 1360–1367, Sep. 2021
  2. “Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial.”.
    A. Matikas et al.
    Clin Cancer Res, vol. 29, no. 3, pp. 532–540, Feb. 2023
  3. “The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the Swedish phase II randomized PREDIX HER2 trial.”.
    Y. Zhu et al.
    Breast Cancer Research and Treatment, vol. 204, no. 2, pp. 299–308, Apr. 2024