About this 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).
Eligibility criteria
Qualifiers
ATRiBRAVE trial written informed consent, prior to any study specific procedures
Age ≥18 years old
Ability to comply with the study protocol in the investigator's judgment.
Ability to swallow and retain oral medication
Disqualifiers
Diagnosis of ataxia telangiectasia.
Any previous treatment with ATR inhibitors, DNA-damage repair inhibitors.
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
Trial design
Treatments tested in this trial
- Ceralasertib
- Durvalumab
- Nab-paclitaxel
Treatment groups
Sponsors and collaborators
IFOM ETS - The AIRC Institute of Molecular Oncology
Lead sponsor
AstraZeneca
Collaborator