OncoMatch/Clinical Trials/NCT06411457

SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer

Is NCT06411457 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SHR-A1811+Adebrelimab for breast cancer.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06411457Data as of May 2026

Treatment: SHR-A1811+Adebrelimab — To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 expression ≤10% (≤10%)

ER/PgR expression ≤10%

Required: PR (PGR) expression ≤10% (≤10%)

ER/PgR expression ≤10%

Required: HER2 (ERBB2) low expression (IHC 1+, or IHC 2+ and ISH-) (IHC 1+, or IHC 2+ and ISH-)

low HER2 expression (IHC 1+, or IHC 2+ and ISH-)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: taxane

At least one prior treatment with taxane or anthracycline therapy

Must have received: anthracycline

At least one prior treatment with taxane or anthracycline therapy

Cannot have received: anti-HER2 antibody-drug conjugate

Prior treatment with anti-HER2 ADC drugs

Lab requirements

Blood counts

ANC ≥1.5×10^9/L, PLT≥70×10^9/L, HGB ≥90g/L

Kidney function

Cr ≤1.5×ULN, or CrCl ≥50 mL/min (using standard Cockcroft-Gault formula)

Liver function

TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN; Stable liver function for at least 1 week after routine liver protection treatment, as assessed by the investigator

Cardiac function

Left ventricular ejection fraction ≥50%

Blood routine: ANC ≥1.5×10^9/L, PLT≥70×10^9/L, HGB ≥90g/L; Liver function: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN; Stable liver function for at least 1 week after routine liver protection treatment, as assessed by the investigator, is eligible for inclusion; Renal function: Cr ≤1.5×ULN, or CrCl ≥50 mL/min (using standard Cockcroft-Gault formula); Coagulation function: INR ≤1.5/PT ≤1.5×ULN, aPTT ≤1.5×ULN; Left ventricular ejection fraction ≥50%

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

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