HER2-positive Breast Cancer
Conditions
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 taxane therapy To further evaluate the efficacy of A166 versus T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer, based on effectiveness endpoints including: Overall survival (OS) Progression-free survival (PFS) as assessed by investigators Objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and clinical benefit rate (CBR) assessed by both blinded independent central review (BICR) and investigators. To assess the safety profile of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer. To evaluate the immunogenicity of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer. To characterize the pharmacokinetic (PK) profile of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer.
Interventions
DRUGA166
intravenous(IV) infusion (Q3W)
DRUGT-DM1
intravenous(IV) infusion (Q3W)
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form. 2. Breast cancer patients by histopathology and/or cytology documented. 3. 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). 4. Have previously received taxanes. 5. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization. 6. At least one measurable lesion according to RECIST 1.1 criteria
Exclusion criteria
1. Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload. 2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 , T-DM1 (trastuzumab emtansine) or their components. 3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments. 4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses. 5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases. 6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Randomization up to approximately 39 months | PFS as assessed by BICR according to RECIST v 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Randomization up to approximately 48 months | OS, 1-year survival rate, 2-year survival rate, and 3-year survival rate. |
| Objective response rate(ORR) | Randomization up to approximately 39 months | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1 |
| Disease control rate(DCR) | Randomization up to approximately 39 months | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/investigator per RECIST 1.1 |
| Duration of response(DOR) | Randomization up to approximately 39 months | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first. |
Countries
China
Outcome results
None listed