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OncoMatch/Clinical Trials/NCT06500208

Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC

Is NCT06500208 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide for breast cancer.

Phase 2RecruitingShanghai Jiao Tong University School of MedicineNCT06500208Data as of May 2026

Treatment: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamideInvestigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 IHC ER expression ≥1% (≥1%)

IHC ER expression ≥1%

Required: HER2 (ERBB2) IHC HER2 0 or 1+ (0 or 1+)

IHC HER2 0 or 1+

Required: HER2 (ERBB2) IHC HER2 2+ and no amplification in FISH test (2+ (IHC) and FISH negative)

IHC HER2 2+ and no amplification in FISH test

Required: PD-L1 (CD274) testing required

Available core needle biopsy samples for PD-L1 status testing

Allowed: PR (PGR) PR-

Grade 2 with PR- or Ki67 > 20%

Allowed: MKI67 Ki67 > 20%

Grade 2 with PR- or Ki67 > 20%

Disease stage

Required: Stage CT1C-T2N1-3, CT3-4N0-3 (clinical TNM)

Excluded: Stage IV

Grade: Grade 3Grade 2 with PR- or Ki67 > 20%

cT1c-T2N1-3 or cT3-4N0-3; Tumor Grade 3 or Grade 2 with PR- or Ki67 > 20%

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: immunotherapy targeting PD-1/PD-L1/T cell receptors

History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors

Lab requirements

Blood counts

intact hematologic function

Kidney function

intact renal function

Liver function

intact liver function

Cardiac function

intact heart function

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

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