ADAPTcycle: Adjuvant dynamic marker-adjusted personalized therapy (ADAPT) comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk HR+/HER2- early breast cancer (EBC)
In: Journal of Clinical Oncology, Jg. 38 (2020-05-20), S. TPS601
Online
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Zugriff:
TPS601 Background: The WSG ADAPT trial program represents the concept of individualization of (neo)-adjuvant decision-making in EBC in a subtype-specific manner. The first WSG ADAPT umbrella trial aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment. The goals of the WSG ADAPT trial program are early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit. Methods: WSG-ADAPTcycle is a prospective, multi-center, interventional, two-arm, open-label, (neo)adjuvant, non-blinded, randomized, controlled phase III trial (NCT04055493). It investigates whether patients (pts.) with HR+/HER2- EBC identified during screening as intermediate risk (based on Oncotype DX and response to 3 weeks of preoperative endocrine therapy [ET]) derive additional benefit from 2 years of the CDK4/6 inhibitor ribociclib combined with ET compared to chemotherapy (CT) (followed by standard ET). Co-primary endpoints are disease-free survival (DFS) and distant DFS. It is planned to screen 5600 pts and to randomize 1670 pts in a 3:2 ratio (ribociclib + ET/CT). Study start was in July 2019 (80 sites, enrollment period 36 months) and until date of submission, 180 pts. have been screened and 40 randomized. Pts with HR+/HER2- EBC with clinically enhanced risk (cT2-4 or Ki67 20% or G3 or cN+) are eligible if they fulfill the ADAPT intermediate-risk group criteria: either Recurrence Score (RS) ≤25 and Ki67postendocrine>10%, RS >25 and Ki67postendocrinepostendocrine
Titel: |
ADAPTcycle: Adjuvant dynamic marker-adjusted personalized therapy (ADAPT) comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk HR+/HER2- early breast cancer (EBC)
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Autor/in / Beteiligte Person: | Schinkoethe, Timo ; Harbeck, Nadia ; Thill, Marc ; Nitz, Ulrike ; Krauss, Katja ; Christgen, Matthias ; Kates, Ronald E. ; Wuerstlein, Rachel ; Just, Marianne ; Hilpert, Felix ; Gluz, Oleg ; Müller, Volkmar ; Graeser, Monika ; Kreipe, Hans ; Kuemmel, Sherko ; Warm, Mathias ; Braun, Michael |
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Zeitschrift: | Journal of Clinical Oncology, Jg. 38 (2020-05-20), S. TPS601 |
Veröffentlichung: | American Society of Clinical Oncology (ASCO), 2020 |
Medientyp: | unknown |
ISSN: | 1527-7755 (print) ; 0732-183X (print) |
DOI: | 10.1200/jco.2020.38.15_suppl.tps601 |
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