EICHORCondition: Breast Cancer · Triple-negative Breast Cancer · Sponsor: Women's Cancer Study Group GmbH
TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0/is ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio \[HR\] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% \[REFs\], whereas the addition of platinum increases pCR rates to approximately 50-55%. The KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC. Despite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial: 1. Do all patients require the…
This description comes directly from the study's public registry record.
Anja Braschoß · 017682119153 · regulatory@wsg-online.com
Marina Mangold, Dr · 02161566230 · marina.mangold@wsg-online.com
Always discuss trial participation with your own doctor first.
| SLK-Kliniken Heilbronn GmbH, Klinik für Gynäkologie und Geburtshilfe | Heilbronn, Baden-Wurttemberg, Germany | — |
| GRN Gesundheitszentren Rhein-Neckar gGmbH, Brustzentrum Weinheim | Weinheim, Baden-Wurttemberg, Germany | — |
| Universitaetsklinikum Augsburg, Klinik für Frauenheilkunde und Geburtsmedizin | Augsburg, Bavaria, Germany | — |
| Klinikum der Universitaet Muenchen AöR, Frauenheilkunde und Geburtshilfe | München, Bavaria, Germany | — |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum), Brustzentrum | München, Bavaria, Germany | — |
| Caritas-Krankenhaus St. Josef, Frauenheilkunde und Geburtshilfe | Regensburg, Bavaria, Germany | — |
| Haematologisch Onkologische Schwerpunktpraxis | Würzburg, Bavaria, Germany | — |
| Medical University Of Lausitz Carl Thiem, Frauenklinik | Cottbus, Brandenburg, Germany | — |
| Gesundheitszentrum Wetterau gGmbH, Gynäkologische Ambulanz | Bad Nauheim, Hesse, Germany | — |
| Klinikum Kassel GmbH, Klinik für Frauenheilkunde und Geburtshilfe | Kassel, Hesse, Germany | — |
| Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz | Hildesheim, Lower Saxony, Germany | — |
| Universitaetsklinikum Aachen AöR, Gynäkologie und Geburtsmedizin | Aachen, North Rhine-Westphalia, Germany | — |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07178730