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OncoMatch/Clinical Trials/NCT06331169

Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

Is NCT06331169 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Anlotinib and Trastuzumab deruxtecan for breast cancer.

Phase 1RecruitingFudan UniversityNCT06331169Data as of May 2026

Treatment: Anlotinib · Trastuzumab deruxtecanThis study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) low expression (IHC 1+ & IHC 2+/ISH- or 0<IHC<1+) (IHC 1+ or IHC 2+/ISH- or 0<IHC<1+)

Has a history of low HER2 expression (IHC 1+ & IHC 2+/ISH- or 0<IHC<1+)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: endocrine therapy — recurrent or metastatic

Has progressed on, and would no longer benefit from, endocrine therapy

Must have received: chemotherapy — recurrent or metastatic

Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting

Cannot have received: anti-angiogenic targeted small molecule therapy

Has previously been treated with anti-angiogenic targeted small molecule therapy

Cannot have received: antibody-drug conjugate (topoisomerase I inhibitor exatecan derivative)

Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative

Lab requirements

Blood counts

protocol-defined adequate bone marrow function

Kidney function

protocol-defined adequate renal function

Liver function

protocol-defined adequate hepatic function

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

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