drugset / Trial / NCT01815242
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.
Timeline
- Start
- 2013-06
- Primary completion
- 2015-03
- Completion
- 2025-01-15
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.
- Korbie D, Stirzaker C, Gluz O, Zu Eulenburg C, Nitz U, Christgen M, Kuemmel S, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Pelz E, Kreipe HH, Clark SJ, Trau M, Graeser M, Harbeck N. Immunomodulatory gene networks predict treatment response and survival to de-escalated, anthracycline-free neoadjuvant chemotherapy in triple-negative breast cancer in the WSG-ADAPT-TN trial. Mol Cancer. 2025 Mar 26;24(1):96. doi: 10.1186/s12943-025-02275-0.
- Richters L, Gluz O, Weber-Lassalle N, Christgen M, Haverkamp H, Kuemmel S, Kayali M, Kates RE, Grischke EM, Altmuller J, Forstbauer H, Thiele H, Braun M, Warm M, Ossowski A, Wuerstlein R, Ernst C, Graeser M, Linn SC, Nitz U, Hauke J, Kreipe HH, Schmutzler RK, Hahnen E, Harbeck N. Genetic Alterations, Therapy Response, and Survival Among Patients With Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461639. doi: 10.1001/jamanetworkopen.2024.61639.
- Kolberg-Liedtke C, Feuerhake F, Garke M, Christgen M, Kates R, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Graeser M, Nitz U, Kreipe H, Gluz O, Harbeck N. Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial. Breast Cancer Res. 2022 Sep 2;24(1):58. doi: 10.1186/s13058-022-01552-w.
- Gluz O, Nitz U, Kolberg-Liedtke C, Prat A, Christgen M, Kuemmel S, Mohammadian MP, Gebauer D, Kates R, Pare L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Graeser M, Pelz E, Jozwiak K, Zu Eulenburg C, Kreipe HH, Harbeck N; ADAPT TN investigators. De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial. Clin Cancer Res. 2022 Nov 14;28(22):4995-5003. doi: 10.1158/1078-0432.CCR-22-0482.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Background | Nab-paclitaxel | Small molecule | 125 mg/m2 | — |