drugset / Trial / NCT03554109
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).
Timeline
- Start
- 2018-09
- Primary completion
- 2020-06
- Completion
- 2022-02-09
Outcome
Outcome not reported
Stopped: “Trial not initiated”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aldoxorubicin | Small molecule | — | — |
| Subject | Avelumab | Monoclonal antibody | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Subject | ETBX-011 | Vaccine | — | — |
| Subject | ETBX-051 | Vaccine | — | — |
| Subject | ETBX-061 | Vaccine | — | — |
| Subject | GI-4000 | Vaccine | — | — |
| Subject | GI-6207 | Vaccine | — | — |
| Subject | GI-6301 | Vaccine | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | N-803 | Protein / enzyme biologic | — | — |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |
| Subject | haNK | Cell therapy | — | — |