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Breast Diseases

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Amino Acids

Capecitabine

Trastuzumab

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Lapatinib

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Tyrosine

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.

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.

3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.

BAT8001 for injection

Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.

Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Shusen Wang, M.D.

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).

The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China

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.

OS is defined as the time from the date of randomization to the date of death from any cause.

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.

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.

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;

Concentration of BAT8001 will be measured in serum from participants, who received BAT8001.

Concentration of total antibody will be measured in serum from participants, who received BAT8001.

Concentration of batansine will be measured in plasma from participants, who received BAT8001.

ATA to BAT8001 were measured in serum of participants, who received BAT8001.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer	NCT04185649	HER2-positive A...	BAT8001 for inj... Lapatinib Capecitabine	18 Years - 75 Years	Bio-Thera Solutions
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer	NCT04185649	HER2-positive A...	BAT8001 for inj... Lapatinib Capecitabine	18 Years - 75 Years	Bio-Thera Solutions

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