HER2-positive Advanced Breast Cancer Clinical Trial
Official title:
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
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).
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