Phase
Condition
Cancer
Breast Cancer
Treatment
ARX788
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 to 75 years old (including upper and lower limits), male or female;
Unresectable locally advanced, recurrent or metastatic BC;
Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
Received T-DXd treatment in the advanced stage;
Adequate bone marrow, liver, kidney and coagulation function;
Voluntarily sign the informed consent, have good compliance and are willing tocomply with the follow-up visit.
Exclusion
Exclusion Criteria:
With meningeal metastases or disseminated brain metastases or active brainmetastases;
Has interstitial lung disease requiring steroid therapy, a history of drug-inducedinterstitial lung disease, a history of radiation pneumonitis, or any evidenceindicating clinically active interstitial lung disease;
Has any eye disease that require medical intervention such as keratitis, cornealdiseases or active eye infection;
Has cardiac insufficiency;
Has received any systemic anti-tumor therapy (with the exception of endocrinetherapy, with an interval of at least 7 days) within 28 days (or at least 5half-lives) before the first use of the investigational product;