A Phase 3 interventional study of BAT8001 for injection and Lapatinib in HER2-positive Advanced Breast Cancer, sponsored by Bio-Thera Solutions. Status unknown at 51 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Bio-Thera Solutions · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
This is a multicenter, randomized, open-label, positive-controlled, superiority phase III clinical study. The object is to evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
Eligible subjects will be randomized to the experimental or control group in a 1:1 ratio and stratified by the number of HER2-positive advanced/metastatic breast cancer treatment regimens (0, 1 VS > 1) and lesion site (organ VS non-organ).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 410 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Bio-Thera Solutions is the lead sponsor of 54 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Biological: BAT8001 for injection
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Drug: Lapatinib · Drug: Capecitabine
3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Also known as: Lapatinib ditosylate tablets
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Also known as: capecitabine tablets
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version (v1.1), or death from any cause during the study, whichever occurs first.
Time frame: Up to approximately 18 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.
Time frame: Up to approximately 30 months
Objective Response Rate (ORR)
ORR is defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1.
Time frame: Up to approximately 30 months
Duration of Response (DOR)
DOR is defined as as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study.
Time frame: Up to approximately 30 months
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects with best overall response (confirmed PR or CR) or with stable disease (confirmed SD) for at least 6 months;
Time frame: Up to approximately 30 months
Serum Concentration of BAT8001
Concentration of BAT8001 will be measured in serum from participants, who received BAT8001.
Time frame: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)
Serum Concentration of total antibody of BAT8001 for injection
Concentration of total antibody will be measured in serum from participants, who received BAT8001.
Time frame: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)
Plasma Concentration of batansine (a maytansine derivative, which is the 3AA-MDC complex)
Concentration of batansine will be measured in plasma from participants, who received BAT8001.
Time frame: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)
Percentage of Participants with Anti-therapeutic Antibodies (ATA) to BAT8001
ATA to BAT8001 were measured in serum of participants, who received BAT8001.
Time frame: Pre-dose on Day 1 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)
Plan to share: No
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