A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
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: A166.
- Who it may be relevant to
- Registry conditions: Her 2 Positive 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
- China
- 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
Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs
Overview
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
Detailed description
This study will evaluate the efficacy of A166 in patients with HER2-positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates.
A166 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
Interventions
- Drug A166
intravenous(IV) infusion (Q3W)
Primary outcome measures
- Objective response rate(ORR) [Time frame: Within 24 months of last patient enrolled]
Secondary outcome measures (5)
- Progression-free survival (PFS) [Time frame: Within 24 months of last patient enrolled]
- Overall survival (OS) [Time frame: Within 48 months of last patient enrolled]
- Disease control rate(DCR) [Time frame: Within 24 months of last patient enrolled]
- Duration of response(DOR) [Time frame: Within 24 months of last patient enrolled]
- Clinical Benefit Rate (CBR) [Time frame: Within 24 months of last patient enrolled]
Eligibility criteria
Inclusion criteria
- Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
- Breast cancer patients by histopathology and/or cytology documented.
- In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.
- Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
- At least one measurable lesion according to RECIST 1.1 criteria.
Exclusion criteria
- Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
- Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
- Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
- Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
- Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
- Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
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
China · 1 center
- Henan Provincial Cancer Hospital — Zhenzhou
Identifiers
NCT: NCT07299825 · KL166-II-08