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OncoMatch/Clinical Trials/NCT05814354

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

Is NCT05814354 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel for breast cancer.

Phase 3RecruitingJiangsu HengRui Medicine Co., Ltd.NCT05814354Data as of May 2026

Treatment: SHR-A1811 · Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxelThe aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) low expression (IHC 2+/ISH- or IHC 1+ [ISH- or untested]) (IHC 2+/ISH- or IHC 1+ (ISH- or untested))

Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).

Required: ESR1 positive

HR-positive breast cancer

Disease stage

Metastatic disease required

Prior therapy

Max 1 prior line
Min 0 prior lines

Must have received: endocrine therapy — metastatic

Lab requirements

Blood counts

protocol-defined adequate bone marrow function

Kidney function

protocol-defined adequate renal function

Liver function

protocol-defined adequate hepatic function

Cardiac function

protocol-defined adequate cardiac function

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

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