The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
381
SHR-A1811 4.8mg/kg
Pyrotinib in combination with Capecitabine.
SHR-A1811 6.4mg/kg
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
PFS(BIRC assessment)between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine.
Time frame: 6 weeks after the first study drug administration,about 2 years.
PFS(INV assessment)between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine
Time frame: 6 weeks after the first study drug administration,about 2 years.
ORR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 2 years.
DoR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 2 years.
OS between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 4 years.
PFS(BIRC assessment)between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: 6 weeks after the first study drug administration,about 2 years.
PFS(INV assessment)between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: 6 weeks after the first study drug administration,about 2 years.
ORR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 2 years.
DoR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 2 years.
OS between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine;
Time frame: about 4 years.
AE
Time frame: about 2 years.
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