Status:
ACTIVE_NOT_RECRUITING
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Lead Sponsor:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions:
HER2-positive Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
Detailed Description
This study will evaluate the efficacy of A166 versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxan...
Eligibility Criteria
Inclusion
- Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
- Breast cancer patients by histopathology and/or cytology documented.
- Disease progression after receiving a trastuzumab-based regimen (or a commercially available trastuzumab biosimilar or inetetamab) in the advanced or metastatic setting, or disease progression/recurrence within 12 months during or after (neo)adjuvant therapy (with a trastuzumab-based regimen or commercially available trastuzumab biosimilar).
- Have previously received taxanes.
- 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
- 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 , T-DM1 (trastuzumab emtansine) 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
Key Trial Info
Start Date :
July 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2028
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT06968585
Start Date
July 18 2023
End Date
March 31 2028
Last Update
May 13 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032