ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Summary

Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.

Timeline

Start

2012-05

Primary completion

2019-09

Completion

2025-01-15

Outcome

Met primary endpoint

paper One-sided 95% lower confidence limit of the 5y-iDFS difference was -3.3%, establishing prespecified noninferiority (P = .05). PMID 35404683 ↗

Publications

• Background Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261.
• Zhang G, Jurinovic V, Bartels S, Christgen M, Christgen H, Kandt LD, Mishieva L, Ni H, Raap M, Klein J, Katzke AL, Hofmann W, Steinemann D, Kates RE, Gluz O, Graeser M, Kummel S, Nitz U, Plass C, Lehmann U, Zu Eulenburg C, Mansmann U, Gerhauser C, Harbeck N, Kreipe HH. A predictive endocrine resistance index accurately stratifies luminal breast cancer treatment responders and nonresponders. J Clin Invest. 2025 Jul 24;135(19):e177813. doi: 10.1172/JCI177813. eCollection 2025 Oct 1.
• Gluz O, Kuemmel S, Nitz U, Braun M, Ludtke-Heckenkamp K, von Schumann R, Darsow M, Forstbauer H, Potenberg J, Uleer C, Grischke EM, Aktas B, Schumacher C, Zu Eulenburg C, Kates R, Jozwiak K, Graeser M, Wuerstlein R, Baehner R, Christgen M, Kreipe HH, Harbeck N. Nab-paclitaxel weekly versus dose-dense solvent-based paclitaxel followed by dose-dense epirubicin plus cyclophosphamide in high-risk HR+/HER2- early breast cancer: results from the neoadjuvant part of the WSG-ADAPT-HR+/HER2- trial. Ann Oncol. 2023 Jun;34(6):531-542. doi: 10.1016/j.annonc.2023.04.002. Epub 2023 Apr 14.
• Harbeck N, Nitz UA, Christgen M, Kummel S, Braun M, Schumacher C, Potenberg J, Tio J, Aktas B, Forstbauer H, Grischke EM, Scheffen I, Malter W, von Schumann R, Just M, Zu Eulenburg C, Biehl C, Kolberg-Liedtke C, Deurloo R, de Haas S, Jozwiak K, Hauptmann M, Kates R, Graeser M, Wuerstlein R, Kreipe HH, Gluz O; WSG-ADAPT investigators. De-Escalated Neoadjuvant Trastuzumab-Emtansine With or Without Endocrine Therapy Versus Trastuzumab With Endocrine Therapy in HR+/HER2+ Early Breast Cancer: 5-Year Survival in the WSG-ADAPT-TP Trial. J Clin Oncol. 2023 Aug 1;41(22):3796-3804. doi: 10.1200/JCO.22.01816. Epub 2023 Feb 21.
• Nitz UA, Gluz O, Kummel S, Christgen M, Braun M, Aktas B, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Schumacher C, Darsow M, Krauss K, Nuding B, Thill M, Potenberg J, Uleer C, Warm M, Fischer HH, Malter W, Hauptmann M, Kates RE, Graser M, Wurstlein R, Shak S, Baehner F, Kreipe HH, Harbeck N. Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2- Early Breast Cancer. J Clin Oncol. 2022 Aug 10;40(23):2557-2567. doi: 10.1200/JCO.21.02759. Epub 2022 Apr 11.
• Graeser M, Schrading S, Gluz O, Strobel K, Herzog C, Umutlu L, Frydrychowicz A, Rjosk-Dendorfer D, Wurstlein R, Culemann R, Eulenburg C, Adams J, Nitzsche H, Prange A, Kummel S, Grischke EM, Forstbauer H, Braun M, Potenberg J, von Schumann R, Aktas B, Kolberg-Liedtke C, Harbeck N, Kuhl CK, Nitz U. Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials. Breast Cancer Res. 2021 Mar 18;23(1):36. doi: 10.1186/s13058-021-01413-y.
• Nitz U, Gluz O, Kreipe HH, Christgen M, Kuemmel S, Baehner FL, Shak S, Aktas B, Braun M, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Nuding B, Darsow M, Schumacher C, Krauss K, Malter W, Thill M, Warm M, Wuerstlein R, Kates RE, Harbeck N. The run-in phase of the prospective WSG-ADAPT HR+/HER2- trial demonstrates the feasibility of a study design combining static and dynamic biomarker assessments for individualized therapy in early breast cancer. Ther Adv Med Oncol. 2020 Nov 23;12:1758835920973130. doi: 10.1177/1758835920973130. eCollection 2020.

Drugs

Indications