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

NCT05582538 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-08-24

No results posted yet for this study

Summary

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).

Conditions

  • Triple Negative Breast Cancer Metastatic

Interventions

DRUG

Ceralasertib

240mg orally BD (dose level 0) on days -6 to 0 prior to day 1 cycle 1 and then on days 22 to 28 of cycle 1 and every subsequent cycle

DRUG

Durvalumab

1500 mg i.v. day 1 (q28)

DRUG

Nab-paclitaxel

100mg/m2 i.v. day 1,8,15 (q28)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • IFOM ETS - The AIRC Institute of Molecular Oncology

    lead OTHER

Principal Investigators

  • Silvia Marsoni, MD · IFOM ETS - The AIRC Institute of Molecular Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582538 on ClinicalTrials.gov