Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology

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

37 Participants
are divided into 1 treatment group

Sponsors and collaborators