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Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel: The ATRiBRAVE Trial
This study will evaluate the efficacy and safety of ceralasertib followed by durvalumab plus nab-paclitaxel in 37 patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included immunotherapy and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both).
Details
| Lead sponsor | IFOM ETS - The AIRC Institute of Molecular Oncology |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 37 |
| Start date | 2022-12-15 |
| Completion | 2029-12 |
Conditions
- Triple Negative Breast Cancer Metastatic
Interventions
- Ceralasertib
- Durvalumab
- Nab-paclitaxel
Primary outcomes
- Progression free survival (PFS) — From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
ATRiBRAVE will evaluate the efficacy of ceralasertib followed by durvalumab plus nab-paclitaxel in patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included ICIs and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both).
Countries
Italy