Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05582538

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

Led by IFOM ETS - The AIRC Institute of Molecular Oncology · Updated on 2025-08-24

37

Participants Needed

6

Research Sites

363 weeks

Total Duration

On this page

Sponsors

I

IFOM ETS - The AIRC Institute of Molecular Oncology

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent for the ATRiBRAVE trial before any study procedures
  • At least 18 years old
  • Able to follow the study protocol as judged by the investigator
  • Able to swallow and retain oral medication
  • Availability of primary tumor tissue samples or sufficient unstained tumor slides
  • Metastatic TNBC patients with no prior systemic cytotoxic therapy in advanced setting and tumor relapse after curative intent treatment including immunotherapy and chemotherapy
  • Documented disease progression since last early-stage treatment
  • Confirmed negative ER/PgR (less than 10% expression) and HER2 status in recent tumor samples
  • Measurable disease according to RECIST 1.1
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months from first dose
  • Acceptable bone marrow, liver, and kidney function within 28 days before treatment
  • Body weight over 30 kg
  • Women of childbearing potential must have a negative pregnancy test within 28 days before treatment and agree to use effective contraception until 90 days after last durvalumab dose
  • Men must agree to abstain from heterosexual intercourse or use contraception and agree not to donate sperm until 90 days after last durvalumab dose
Not Eligible

You will not qualify if you...

  • Diagnosis of ataxia telangiectasia
  • Previous treatment with ATR inhibitors or DNA-damage repair inhibitors
  • Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with severe immune-related side effects or ongoing immunosuppression above allowed levels
  • Use of investigational products within 28 days before enrollment
  • Inadequate washout period from prior cancer therapies or major surgeries
  • Use of immunosuppressive medication within 4 weeks before durvalumab except allowed corticosteroids
  • Second primary cancer unless adequately treated and no evidence of disease for 3 years
  • Gastrointestinal conditions preventing proper absorption of ceralasertib
  • Active or prior autoimmune or inflammatory disorders except specified stable conditions
  • Active hepatitis B or C infection or HIV
  • Recent live vaccine within 30 days before treatment
  • Unrecovered COVID-19 infection
  • History of organ transplantation
  • Untreated or unstable central nervous system metastases
  • History of leptomeningeal disease
  • Unresolved severe toxicity from prior cancer therapy
  • Significant cardiac problems or abnormal ECG findings
  • Recent stroke or transient ischemic attack
  • Uncontrolled fluid accumulations or hypercalcemia
  • Recent severe infection or antibiotic treatment
  • Severe or uncontrolled systemic diseases posing risk
  • Use of strong CYP3A inhibitors or inducers without proper washout
  • Use of medications or supplements affecting Pgp activity without washout
  • Known allergy to study drugs or their ingredients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Novara, Italy

Actively Recruiting

2

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Actively Recruiting

3

Istituto Nazionale dei Tumori IRCCS

Milan, Italy

Actively Recruiting

4

IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

Naples, Italy, 80131

Actively Recruiting

5

Istituto Oncologico Veneto IRCCS

Padova, Italy

Actively Recruiting

6

Azienda U.S.L. - IRCCS di Reggio Emilia

Reggio Emilia, Italy

Actively Recruiting

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Research Team

Y

Ylenia Silvestri, PhD

CONTACT

S

Smeralda Rapisarda, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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