OncoMatch/Clinical Trials/NCT05582538

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

Is NCT05582538 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ceralasertib and Durvalumab for triple negative breast cancer metastatic.

Phase 2RecruitingIFOM ETS - The AIRC Institute of Molecular OncologyNCT05582538Data as of May 2026

Treatment: Ceralasertib · Durvalumab · Nab-paclitaxel — 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).

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 wild-type (<10% of tumor cells expressing ER)

Negative ER/PgR (defined as <10% of tumor cells expressing ER and PgR hormonal receptors)

Required: PR (PGR) wild-type (<10% of tumor cells expressing PgR)

Negative ER/PgR (defined as <10% of tumor cells expressing ER and PgR hormonal receptors)

Required: HER2 (ERBB2) wild-type (HER2 IHC score 0, 1+ or 2+ non-amplified by in situ hybridization)

HER2 status (HER2 IHC score 0, 1+ or 2+ non-amplified by in situ hybridization) must be confirmed

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: immune checkpoint inhibitor — early disease (curative intent, neo/adjuvant)

tumor have relapsed from treatment with curative intent for early disease, which must have included ICI and chemotherapy as part of radical locoregional therapy

Must have received: chemotherapy — early disease (curative intent, neo/adjuvant)

tumor have relapsed from treatment with curative intent for early disease, which must have included ICI and chemotherapy as part of radical locoregional therapy

Cannot have received: systemic cytotoxic therapy

Exception: in the advanced setting

have not received prior systemic cytotoxic therapy in the advanced setting

Cannot have received: ATR inhibitor

Any previous treatment with ATR inhibitors

Cannot have received: DNA-damage repair inhibitor

Any previous treatment with...DNA-damage repair inhibitors

Lab requirements

Blood counts

acceptable bone marrow function measured within 28 days prior to administration of study treatment

Kidney function

acceptable renal function measured within 28 days prior to administration of study treatment

Liver function

acceptable liver function measured within 28 days prior to administration of study treatment

Patients must have acceptable bone marrow, liver and renal functions measured within 28 days prior to administration of study treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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