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.
Treatment: Anlotinib · Trastuzumab deruxtecan — This 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.
Check if I qualifyExtracted 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
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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