ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARX788.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy
Overview
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
Interventions
- Drug ARX788
ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
Primary outcome measures
- Objective remission rate (ORR) [Time frame: Until progression, assessed up to approximately 24 months]
Secondary outcome measures (5)
- Disease control rate (DCR) [Time frame: Baseline through end of study, assessed up to 24 months]]
- Duration of relief (DOR) [Time frame: Until progression, assessed up to approximately 24 months]
- Progression-free survival (PFS) [Time frame: Until progression or death, assessed up to approximately 36 months]]
- Overall survival (OS) [Time frame: Until death, assessed up to approximately 50 months]
- The number of subjects experiencing adverse event TEAEs [Time frame: Up to follow-up period, approximately 50 months]
Eligibility criteria
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 to comply with the follow-up visit.
Exclusion criteria
- With meningeal metastases or disseminated brain metastases or active brain metastases;
- Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- Has cardiac insufficiency;
- Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06578286 · ACE-Breast-10