drugset / Trial / NCT02101385
Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
Phase 2
Completed
193 enrolled
Bryan Schneider, MD
Hoosier Cancer Research Network · collabIndiana University · collabVera Bradley Foundation for Breast Cancer · collabWalther Cancer Institute · collab
RandomizedFactorialOpen-labelTreatment
Summary
This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard.
Timeline
- Start
- 2014-04-03
- Primary completion
- 2021-02-21
- Completion
- 2022-09-09
Outcome
Missed primary endpoint
paper Genomically directed therapy was not superior to TPC for patients with residual TNBC after NAC. PMID 34910554 ↗
Publications
- Xu J, Gao H, Guan X, Meng J, Ding S, Long Q, Yi W. Circulating tumor DNA: from discovery to clinical application in breast cancer. Front Immunol. 2024 Apr 30;15:1355887. doi: 10.3389/fimmu.2024.1355887. eCollection 2024.
- Schneider BP, Jiang G, Ballinger TJ, Shen F, Chitambar C, Nanda R, Falkson C, Lynce FC, Gallagher C, Isaacs C, Blaya M, Paplomata E, Walling R, Daily K, Mahtani R, Thompson MA, Graham R, Cooper ME, Pavlick DC, Albacker LA, Gregg J, Solzak JP, Chen YH, Bales CL, Cantor E, Hancock BA, Kassem N, Helft P, O'Neil B, Storniolo AMV, Badve S, Miller KD, Radovich M. BRE12-158: A Postneoadjuvant, Randomized Phase II Trial of Personalized Therapy Versus Treatment of Physician's Choice for Patients With Residual Triple-Negative Breast Cancer. J Clin Oncol. 2022 Feb 1;40(4):345-355. doi: 10.1200/JCO.21.01657. Epub 2021 Dec 15.
- Radovich M, Jiang G, Hancock BA, Chitambar C, Nanda R, Falkson C, Lynce FC, Gallagher C, Isaacs C, Blaya M, Paplomata E, Walling R, Daily K, Mahtani R, Thompson MA, Graham R, Cooper ME, Pavlick DC, Albacker LA, Gregg J, Solzak JP, Chen YH, Bales CL, Cantor E, Shen F, Storniolo AMV, Badve S, Ballinger TJ, Chang CL, Zhong Y, Savran C, Miller KD, Schneider BP. Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1410-1415. doi: 10.1001/jamaoncol.2020.2295.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Celecoxib | Other / unclassified | — | — |
| Subject | Cetuximab | Monoclonal antibody | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Crizotinib | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Everolimus | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Octreotide | Peptide | — | — |
| Subject | Olaparib | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Temozolomide | Small molecule | — | — |