OncoMatch/Clinical Trials/NCT06331169
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Is NCT06331169 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06331169 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-angiogenic targeted small molecule therapy, antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 low expression (IHC 1+ & IHC 2+/ISH- or 0<IHC<1+) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify