A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable … (NCT06968585) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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
China365 participantsStarted 2023-07-18
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
✓. 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 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 , 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.
✕
What they're measuring
1
Progression-free survival (PFS)
Timeframe: Randomization up to approximately 39 months