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@ARTICLE{Pixberg:300737,
      author       = {C. Pixberg and C. Maurer and K. Smetanay and L. Straßl and
                      M. Hlevnjak and M. Zapatka$^*$ and C. V. Wagner and H.
                      Yazdanparast and J. Kurzawa and V. Erben and F. Feng$^*$ and
                      C. Hong$^*$ and D. Hübschmann$^*$ and L. Buschhorn and J.
                      P. Suppelna and L. Michel and S. Heublein and C. Fremd and
                      O. Zivanovic and P. Sinn and A. Stenzinger and R. Haidinger
                      and E. Schumacher-Wulf and N. Ditsch and S. Loibl and S.
                      Fröhling$^*$ and T. Link and P. Wimberger and J.-U. Blohmer
                      and H. Huebner and P. A. Fasching and W. Janni and R. F.
                      Schlenk and V. Thewes and P. Lichter$^*$ and A. Schneeweiss},
      title        = {{COGNITION}-{GUIDE} – {G}enomics-{G}uided {T}argeted
                      {P}ost-{N}eoadjuvant {T}herapy in {P}atients with {E}arly
                      {B}reast {C}ancer: {S}tudy {D}esign of a {M}ulticenter,
                      {O}pen-{L}abel, {U}mbrella {P}hase {II} {S}tudy},
      journal      = {Geburtshilfe und Frauenheilkunde},
      volume       = {85},
      number       = {6},
      issn         = {0016-5751},
      address      = {New York, NY},
      publisher    = {Thieme},
      reportid     = {DKFZ-2025-00897},
      pages        = {611-619},
      year         = {2025},
      note         = {#LA:B060# / 2025 Apr 10;85(6):611-619},
      abstract     = {Background: As part of the COGNITION diagnostic registry
                      program, residual tumor material after neoadjuvant therapy
                      (NAT) of patients with early breast cancer (eBC), who are
                      still at high-risk for relapse after NAT, is analyzed by
                      next generation sequencing to identify biomarkers and
                      actionable alterations. This strategy aims to stratify
                      patients for subsequent genomics-guided therapies to reduce
                      the significant risk of metastatic dissemination and hence
                      to improve disease-free survival. Patients and Methods:
                      COGNITION-GUIDE is a multicenter umbrella phase-II-trial to
                      translate molecular biomarker profiles generated in the
                      COGNITION platform into six molecular-guided
                      post-neoadjuvant therapeutic options in addition to
                      standard-of-care treatment. Patients can be allocated to
                      immune checkpoint inhibition (PD-L1-antibody), PI3K
                      inhibition, AKT inhibition, PARP inhibition, anti-Trop-2
                      antibody-drug-conjugate, HER2 inhibition or, in case of
                      missing biomarkers, to observation for 12 months. The
                      primary endpoint is invasive disease-free survival (IDFS)
                      four years after surgery. Secondary endpoints include IDFS
                      in each study arm separately, distant disease-free survival,
                      overall survival and safety. 240 patients will be enrolled
                      within four years. Conclusions: The COGNITION-GUIDE trial,
                      which was activated in June 2023 and will recruit in
                      different centers in Germany, empowers a risk-adapted,
                      biomarker-guided therapy escalation algorithm in eBC
                      patients who are still at high risk of metastasis.},
      cin          = {B060 / B340 / HD01},
      cid          = {I:(DE-He78)B060-20160331 / I:(DE-He78)B340-20160331 /
                      I:(DE-He78)HD01-20160331},
      pnm          = {312 - Funktionelle und strukturelle Genomforschung
                      (POF4-312)},
      pid          = {G:(DE-HGF)POF4-312},
      typ          = {PUB:(DE-HGF)16},
      doi          = {10.1055/a-2557-1876},
      url          = {https://inrepo02.dkfz.de/record/300737},
}