The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are: * The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy. * The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy. * Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer. Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Enrolled patients will receive Trastuzumab Emtansine (T-DM1) treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGObjective response rate
Time frame: up to 12 months
Progression-free survival
Time frame: up to 36 months
Overall survival
Time frame: up to 36 months
Adverse events
Time frame: every 6 weeks
Antitumor immunity related parameters
The changes of composition and function of immune cells in the tumor and peripheral blood before and after treatment
Time frame: up to 12 weeks
Tumor related parameters
Tumor heterogeneity before and after treatment its correlation with objective response rate, progression-free survival, overall survival, etc.
Time frame: up to 12 weeks
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